FOI Documents 140-000 - 149-999
Listed with Abstracts from the Summaries
NADA 140-008 original approval
Sponsor: Miles Inc.
Generic Name: praziquantel + pyrantel pamoate
Trade Name: Drontal Tablets
Indications for use: Drontal Tablets will remove Tapeworms
(Dipylidium caninum, Taenia taeniaeformis ), Hookworms
(Ancylostoma tubaeforme ) and Large Roundworms (Toxocara
cati ) in kittens and cats.
Date of Approval: September 29, 1993
NADA 140-011 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate + chlortetracycline
(equivalent to chlortetracycline hydrochloride)
Trade Name: Denagard® 10; chlortetracycline premixes
Indications for use: For the control of swine dysentery
associated with Serpulina hyodysenteriae susceptible
to tiamulin and for treatment of swine bacterial enteritis caused
by Escherichia coli and Salmonella choleraesuis
sensitive to chlortetracycline and treatment of bacterial pneumonia
caused by Pasteurella multocida sensitive to chlortetracycline.
Date of Approval: August 20, 1996
NADA
140-269 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: ketoprofen
Trade Name: Ketofen
Indications for use: Ketofen(TM) is indicated for the
alleviation of inflammation and pain associated with musculoskeletal
disorders in the horse.
Date of Approval: September 26, 1990
NADA 140-270 original approval
Sponsor: Medico Industries, Inc.
Generic Name:sulfamethazine
Trade Name: Sulfamethazine Sustained Release Bolus
Indications for use: Sulfamethazine Sustained Release
Bolus is indicated for the treatment of the following diseases
in beef cattle and non-lactating dairy cattle: Bovine respiratory
disease complex (shipping fever complex) associated with Pasteurella
spp.; bacterial pneumonia associated with Pasteurella
spp.; necrotic pododermatitis (foot rot) and calf diphtheria
caused by Fusobacterium necrophorum; colibacillosis (bacterial
scours) caused by Escherichia coli; coccidiosis caused
by Eimeria bovis and E. zurnii; acute mastitis
and metritis caused by Streptococcus spp.
Date of Approval: August 25, 1986
NADA 140-288 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid, tylosin
Trade Name: MGA®100/200 Premix, MGA®500 Liquid
Premix, BOVATEC®, TYLAN®
Effect of Supplement: This supplement provides for removal
of the requirement of a pre-slaughter drug withdrawal period
for heifers fed melengestrol acetate when melengestrol acetate
is fed in combination either with lasalocid or with lasalocid
and tylosin.
Date of Approval: June 29, 1994
NADA 140-338 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Indications for use: Naxcel Sterile Powder is indicated
for treatment of bovine respiratory disease (shipping fever,
pneumonia).
Date of Approval: January 25, 1988
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Effect of Supplement:This supplemental application provides
for a change in the approved dosage of 0.5 mg/lb body weight
to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight.
Date of Approval: April 5, 1990
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCELR® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur
sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a
new class of animal, for the same indications approved in the
parent NADA.
Date of Approval: March 15, 1991
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: This supplement provides for an
additional species, swine, to be added to the previously approved
product, NAXCEL®
Date of Approval: August 4, 1992
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: The supplement provides data in
support of a request for approval of Naxcel ® Sterile Powder
for an additional species (equine). The issue of the Freedom
of Information (FOI) Summary should be considered an extension
of previously approved version describing data in support of
Naxcelreg., NADA 140-338, approved as a treatment for respiratory
disease in cattle January 25, 1988.
Date of Approval: July 13, 1994
NADA 140-338
supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement:Provides for the use of ceftiofur
sodium (NAXCEL® Sterile Powder) in cattle for a new indication.
Date of Approval: August 24, 1995
NADA 140-338
supplemental approval
Sponsor: The Upjohn Company
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement:Provides for an additional species,
day-old turkey poults, to be added to the previously approved
product, NAXCEL® Sterile Powder; also provides for revision
of the chick indication.
Date of Approval: May 21, 1996
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement
will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder)
for the treatment of bacterial pneumonia in sheep.
Date of Approval: October 25, 1996
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Date of Approval: March 7, 2001
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® brand of ceftiofur sodium sterile
powder.
Effect of Supplement: Provides for the use of a subcutaneous
(SC) route of administration for NAXCEL® Sterile Powder
in cattle.
Date of Approval: May 29, 2001
NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement provides four specific
changes to
the product insert, 1) revision of the “clinical microbiology”
section to update the MIC table using the new MIC data for ceftiofur,
2) the addition of a table listing acceptable quality control
ranges for ceftiofur, 3) the addition of the latest National
Committee for Clinical Laboratory Standards (NCCLS) reference
at the end of the insert, and 4) clarification of the statement
under “Storage Conditions” dealing with the storage
of reconstituted Naxcel via freezing.
Date of Approval: December 31, 2003
NADA
140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement:This supplement updates survey microbiological
data and adds the National Committee for Clinical Laboratory
Standards’ (NCCLS) interpretive criteria for equine isolates
to the NAXCEL Sterile Powder package insert.
Date of Approval: February 27, 2004
NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: Naxcel®
Effect of Supplement: For the treatment and control of
swine bacterial respiratory disease (swine bacterial pneumonia)
associated with Actinobacillus (Haemophilus) pleuropneumoniae,
Pasteurella multocida, Salmonella choleraesuis, and Streptococcus
suis type 2.
Date of Approval: June 18, 2004
NADA 140-339 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Nicarbazin, bambermycins
Trade Name: Nicarb®, Flavomycin®
Indications for use: As an aid in preventing outbreaks
of cecal coccidiosis caused by Eimeria tenella, intestinal
coccidiosis caused by E. acervulina, E. maxima, E. nectarix,
and E. brunetti,, increased rate of weight gain and improved
feed efficiency.
Date of Approval: August 6, 1999
NADA 140-340 original approval
Sponsor: Roussel-Uclaf
Generic Names: lincomycin, halofuginone hydrobromide
Trade Names: Lincomix®, Stenorol®
Indications for use: For the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima,
E. mivati, and E. brunetti; and for improved feed
efficiency in broiler chickens.
Date of Approval: March 21, 1989
NADA 140-439 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: EQVALAN Liquid
Indications for use: For treatment and control of the
following parasites or parasitic conditions in horses: bots,
large mouth stomach worms, neck threadworms, pinworms, ascarids,
lungworms, intestinal threadworms, small strongyles large strongyles,
summer sores, and dermatitis caused by neck threadworm microfilariae.
Date of Approval: July 1, 1987
NADA 140-439 supplemental
approval
Sponsor: Merial Ltd.
Generic Name: ivermectin
Trade Name: EQVALAN Liquid For Horses
Effect of Supplement: This supplement amends the EQVALAN
(ivermectin) Oral Liquid For Horses labeling to add four species
of internal parasites and to reflect a change in the Indications
section which separates the listing of adult small strongyle
species from their related fourth-stage larvae. Specifically,
the supplement provides for the use of ivermectin oral liquid
for the treatment and control of Craterostomum acuticaudatum,
Petrovinema poculatum, and Coronocyclus spp.
including Coronocyclus coronatus and Coronocyclus
labratus. In addition, under the sub-heading Small Strongyles,
the labeling has been revised to separate the listing of adult
species from their related fourth-stage larvae.
Date of Approval: August 9, 2004
NADA 140-441 original approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Indications for use: For the treatment of dermal infections,
respiratory infections, and urinary cystitis caused by susceptible
strains of bacteria in dogs.
Date of Approval: December 27, 1988
NADA 140-441 supplemental
approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Effect of Supplement: This supplemental application amends
the NADA to remove the contradiction against use in breeding
female dogs.
Date of Approval: June 6, 1990
NADA 140-441 supplemental
approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable
solution
Trade Name: Baytril® Antibacterial Tablets and Baytril®
Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications,
and limitations.
Date of Approval: June 19, 1997
NADA 140-441 supplemental
approval
Sponsor: Bayer Corp., Agriculture Division, Animal Health
Division
Generic Name: enrofloxacin
Trade Name: Baytril® Taste Tabs Antibacterial
Tablets
Effect of Supplement: For the management of diseases
in dogs and cats associated with bacteria susceptible to enrofloxacin.
Date of Approval: August 3, 1999
NADA 140-442 original approval
Sponsor: Med-Tech, Inc.
Generic Name: xylaxine HCl
Trade Name: Xylazine HCl Injection
Indications for use: Xylazine HCl Injection should be
used in horses when it is desirable to produce a state of sedation.
It has been successfully used when conducting various diagnostic,
orthopedic and dental procedures and for minor surgical procedures
of short duration. It may also be used as a preanesthetic to
local or general anesthesia.
Date of Approval: February 18, 1988
NADA 140-443 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 0.6 and 1.6 Premixes
Indications for use: SWINE: Control of infestations of
large roundworms (Ascaris suis), nodular worms (Oesophagostomum
dentatum) and whipworms (Trichuris suis). CHICKENS:
Control of infestations of large roundworms (Ascaris galli),
cecal worms (Heterakis gallinae), and capillary worms
(Capillaria obsignata). Discontinue swine feeds containing
hygromycin B 15 days before slaughter. Discontinue chicken feeds
containing hygromycin B 3 days before slaughter.
Date of Approval: May 30, 1986
NADA 140-445 original approval
Sponsor: Elanco Products Company
Generic Name: narasin + roxarsone (3-nitro-4-hydroxyphenylarsonic
acid)
Trade Name: Monteban® + Roxarsone
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by bacteria that are more susceptible
to roxarsone combined with narasin than to narasin alone.
Date of Approval: June 28, 1988
NADA 140-448 original approval
Sponsor: Roussel-Uclaf
Generic Name: oxytetracycline + salinomycin sodium
Trade Name: Terramycin + Bio-Cox
Indications for use: As an aid in the reduction of mortality
due to air sacculitis (air sac infection) caused by Escherichia
coli sensitive to oxytetracycline and for the prevention
of coccidiosis caused by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati and E. maxima .
Date of Approval: April 13, 1990
NADA 140-474 original approval
Sponsor: Sterivet Laboratories Limited
Generic Name: hyaluronate sodium
Trade Name: Synacid
Indications for use: For the treatment of equine carpal
and fetlock joint dysfunction caused by traumatic and/or degenerative
joint disease of mile to moderate severity.
Date of Approval: June 1, 1988
NADA 140-530 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate) combined
with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G
Indications for use: For maintaining weight gains and
feed efficiency in the presence of atrophic rhinitis; lowering
the incidence and severity of Bordetella bronchiseptica
rhinitis; prevention of swine dysentery (vibrionic); control
of swine pneumonia caused by bacterial pathogens (Pasteurella
multocida and/or Corynebacterium pyogenes ). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: June 3, 1986
NADA 140-531 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for use: SWINE: For increased rate of weight
gain and improved feed efficiency. BEEF CATTLE: For reduction
of incidence of liver abscesses caused by Sphaerophorus necrophorus
and Corynebacterium pyogenes . CHICKENS: For increased
rate of weight gain and improved feed efficiency. LAYING CHICKENS:
Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS:
To aid in the control of chronic respiratory disease caused
by Mycoplasma gallisepticum .
Date of Approval: July 26, 1986
NADA 140-533 original approval
Sponsor: Roussel-Uclaf
Generic Name: bacitracin methylene disalicylate, roxarsone,
halofuginone hydrobromide
Trade Name: Bacitracin MD, 3-Nitro, Stenorol
Indications for use: For the prevention of coccidiosis
caused by E. tenella, E. acervulina, E. maxima, E. brunetti,
E. necatrix and E. mivati ; For increased rate of
weight gain and for improved feed efficiency in broiler chickens.
Date of Approval: January 11, 1988
NADA 140-578 original approval
Sponsor: Vetri-Tech, Inc.
Generic Name: tetracycline hydrochloride
Trade Name: Solu-Tet 324
Indications for use: Chickens: Control of chronic respiratory
disease (CRD) and air sac infection caused by Mycolplasma
gallisepticum and Esherichia coli; infectious synovitis
caused by Mycoplasma synoviae susceptible tootetracycline.
Date of Approval: February 26, 1991
NADA 140-579 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium, oxytetracycline (monoalkyl
trimethyl ammonium salt)
Trade Name: Bovatec®, Terramycin
Indications for use: For improved feed efficiency, increased
rate of weight gain and reduction of the incidence and severity
of liver abscesses in beef cattle fed in confinement for slaughter.
Date of Approval: December 18, 1987
NADA 140-581 original approval
Sponsor: A. H. Robbins Company, Inc.
Generic Name:salinomycin, roxarsone, and lincomycin
Trade Name: Bio-Cox®, 3-Nitro®, and Lincomix®
(combined use)
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti, and E. mivati
including some field strains of E. tenella that are more
susceptible to roxarsone combined with salinomycin than to salincomycin
alone; and for improved feed efficiency.
Date of Approval: May 31, 1989
NADA 140-582 original approval
Sponsor: Anthony Products Co.
Generic Name: oxytetracycline HCl
Trade Name: Oxytetracycline Hydrochloride Injection,
50 mg and 100 mg
Indications for use: Oxytetracycline HCl (50 mg and 100
mg) is intended for use in the treatment of the following diseases
in beef cattle and non-lactating dairy cattle when due to oxytetracycline-susceptible
organisms: pneumonia and shipping fever complex associated with
Pasteurella spp. and Hemophilus spp.; foot-rot
and diphtheria caused by Fusobacterium necrophorum;bacterial
enteritis (scours) caused by Escherichia coli; wooden
tongue caused by Actinobacillus lignieresii; leptospirosis
caused by Leptospira pomona; and wound infections and
acute metritis caused by strains of staphylococci and streptococci
organisms sensitive to oxytetracycline. If the product contains
the statement "Federal law restricts this drug to use by
or on the order of a licensed veterinarian," it may contain
additional directions for use in beef cattle and non-lactating
dairy cattle for the treatment of anaplasmosis caused by Anaplasma
marginale and anthrax caused by Bacillus anthracis.
Date of Approval: March 15, 1988
NADA 140-583 original approval
Sponsor: Anthony Products Company
Generic Name: repository corticotropin injection
Trade Name: ACTH Gel
Indications for use: ACTH (adrenocorticotropic hormone)
stimulates the production of cortical hormones by the adrenal
cortex. Corticotropin Injection is indicated primarily for use
as a diagnostic aid to test for adrenal dysfunction in dogs.
The product is also indicated for stimulation of the adrenal
cortex, where there is a general deficiency of ACTH in dogs
and cats.
Date of Approval: November 14, 1988
NADA 140-584 original approval
Sponsor: Roussel-Uclaf; Hoechst-Roussel Agri-Vet Company
Generic Name:bacitracin methylene disalicylate; halofuginone
hydrobromide
Trade Name: Bacitracin MD; Stenorol
Indications for use: For the prevention of coccidiosis
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati,
E. necatrix, and E. tenella and improved feed efficiency
in broiler chickens.
Date of Approval: March 16, 1988
NADA 140-680 original approval
Sponsor: Penfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for use: SWINE: For increased rate of weight
gain and improved feed efficiency. For prevention of swine dysentery
(vibrionic). For maintaining weight gains and feed efficiency
in the presence of atrophic rhinitis. For the treatment and
control of swine dysentery (vibrionic) following initial medication
of Tylan Plus Vitamins in drinking water. BEEF CATTLE: For reduction
in the incidence of liver abscesses caused by Sphaerophorus
necrophorus and Corynebacterium pyogenes . CHICKENS:
For increased rate of weight gain and improved feed efficiency.
LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT
CHICKENS: To aid in the control of chronic respiratory disease
caused by Mycoplasma gallisepticum .
Date of Approval: July 24, 1987
NADA 140-681 original approval
Sponsor: Pennfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate) combined
with sulfamethazine
Trade Name: Tylan 5, 10, 20, & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and
feed efficiency in the presence of atrophic rhinitis; lowering
the incidence and severity of Bordetella bronchiseptica
rhinitis; prevention of swine dysentery (vibrionic); control
of swine pneumonia caused by bacterial pathogens (Pasteurella
multocida and/or Corynebacterium pyogenes). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: July 30, 1987
NADA 140-684 original approval
Sponsor: Fort Dodge Laboratories, Inc.
Generic Name: cefadroxil
Trade Name: CEFA-DROPS (cefadroxil) Veterinary Powder
for Oral Suspension
Indications for use: CEFA-DROPS (cefadroxil) is indicated
for the treatment of the following conditions: DOGS: Genitourinary
tract infections (cystitis) caused by susceptible strains of
Escherichia coli, Proteus mirabilis, and Staphylococcus
aureus . Skin and soft tissue infections including cellulitis,
pyoderma, dermatitis, wound infections and abscesses caused
by susceptible strains of Staphylococcus aureus . CATS:
Skin and soft tissue infections including abscesses, wound infections,
cellulitis and dermatitis caused by susceptible strains of Pasteurella
multocida, Staphylococcus aureus, Staphylococcus epidermidis,
and Streptococcus spp.
Date of Approval: July 20, 1988
NADA 140-806 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: hyaluronate sodium
Trade Name: Hyalovet®
Indications for use: For the intra-articular treatment
of carpal or fetlock joint dysfunction in horses due to acute
or chronic, non-infectious synovitis associated with equine
osteoarthritis.
Date of Approval: May 31, 1988
NADA 140-810 original approval
Sponsor: Biomed Laboratories
Generic Name: nystatin, neomycin sulfate, thiostrepton,
triamcinolone acetonide ointment
Trade Name: Panavet Ointment
Indications for use: Panavet Ointment (nystatin, neomycin
sulfate, thiostrepton, triamcinolone acetonide ointment) is
particularly useful in the treatment of acute and chronic otitis
of varied etiologies, in interdigital cysts in cats and dogs,
and in anal gland infections in dogs. The preparation is also
indicated in the management of dermatologic disorders characterized
by inflammation and dry or exudative dermatitis, particularly
those cause, complicated, or threatened by bacterial or candidal
(Candida albicans) infections. It is also of value in eczematous
dermatitis, contact dermatitis, and seborrheic dermatitis, and
as an adjunct in the treatment of dermatitis due to parasitic
infestation.
Date of Approval: February 3, 1989
NADA 140-818
original approval
Sponsor: Merck Research Laboratories
Generic Name:efrotomycin
Trade Name: Producil
Indications for use: For increased rate of weight gain
when incorporated into complete swine feeds at 3.6 to 14.5 g/tons;
for improved feed efficiency when incorporated into complete
swine feeds at 3.6 g/ton.
Date of Approval: July 24, 1992
NADA 140-819 original approval
Sponsor: Pfizer Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid 48
Indications for use: For the prevention of Strongylus
vulgaris larval infections in horses. For control of the
following parasites in horses: LARGE STRONGYLES (adults) S.
vulgaris, S. edentatus, Triodontophorus spp. SMALL STRONGYLES
(adult and fourth-stage larvae) Cyathostomum spp. Cylicocyclus
spp., Cylicostephanus spp., Cylicodontophorus
spp., Poteriostomum spp., PINWORMS (adult and fourth-stage
larvae) Oxyuris equi ASCARIDS (adult and fourth-stage
larvae) Parascaris equorum .
Date of Approval: April 18, 1990
NADA 140-819 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid® 48
Date of Approval: August 24, 1999
NADA 140-820 original approval
Sponsor: Furst-McNess Company
Generic Name: tylosin (as tylosin phosphate) combined
with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and
feed efficiency in the presence of atrophic rhinitis; lowering
the incidence and severity of Bordetella bronchiseptica
rhinitis; prevention of swine dysentery (vibrionic); control
of swine pneumonias caused by bacterial pathogens (Pasteurella
multocida and/or Corynebecterium pyogenes ). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: January 9, 1987
NADA 140-824
supplemental approval
Sponsor: Roussel Uclaf
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol®
Effect of Supplement: Change of tolerance.
Date of Approval: April 14, 1992
NADA 140-825 original approval
Sponsor: Furst-McNess Company
Generic Name: pyrantel tartrate
Trade Name: Swine Wormer-B
Indications for use: CONTINUOUS FEEDING PROGRAM: For
aid in the prevention of migration and establishment of large
round worm (Ascaris suum )infections; for aid in the
prevention of establishment of nodular worm (Oesophagostomum
) infections of swine. Feed continuously as the sole ration.
THREE DAY THERAPEUTIC PROGRAM: For the removal and control of
large roundworm (Ascaris suum ) infections of swine.
Feed for three days as the sole ration. SINGLE THERAPEUTIC PROGRAM:
For the removal and control of large roundworm (Ascaris suum
) and nodular worm (Oesphagostomum ) infections of
swine. Withdraw this feed 24 hours prior to slaughter.
Date of Approval: September 24, 1986
NADA 140-828
original approval
Sponsor: BAYER Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® (enrofloxacin) 3.23% Concentrate
Antimicrobial Solution
Indications for use: Chickens - Baytril® (enrofloxacin)
3.23% Concentrate Antimicrobial Solution is indicated for the
control of mortality associated with E. coli susceptible
to enrofloxacin.
Turkeys - Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial
Solution is indicated for the control of mortality associated
with E. coli and P. multocida (fowl cholera) susceptible
to enrofloxacin.
Date of Approval: October 4, 1996
NADA 140-831 original approval
Sponsor: Argent Chemical Laboratories, Inc.
Generic Name: formalin
Trade Name: Paracide-F
Indications for use: a. Formalin is indicated for the
control of external parasites on cultured sport and food fishes:
salmon, trout, catfish, largemouth bass, and bluegill.
Date of Approval: February 3, 1989
NADA 140-833 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec-F* Injection For Cattle
Indications for use: Ivomec-F Injection For Cattle is
indicated for the treatment and control of the following species
of gastrointestinal nematodes, lungworms, liver flukes, grubs,
sucking lice, and mange mites of cattle.
Date of Approval: November 15, 1989
NADA 140-833 supplemental
approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle.
Effect of Supplement: New claims for persistent control
of gastrointestinal roundworms and lungworms.
Date of Approval: February 24, 1997
NADA 140-833 supplemental
approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: This supplemental application extends
the period of persistent effect against infections of Dictyocaulus
viviparus from 21 days to 28 days.
Date of Approval: March 21,1989
NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: "...has been proved to effectively
control infections and to protect from re-infection with Dictyocaulus
viviparus for 28 days after treatment."
Date of Approval: April 1,1999
NADA 140-833 supplemental
approval
Sponsor: Merial Limited
Generic Name: Ivermectin, clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: To extend the persistent effect
periods for Oesophagostomum
radiatum from 14 to 28 days after treatment and Cooperia punctata
and Trichostrongylus
axei from 14 to 21 days after treatment. At this time, the labeling
is being revised to reflect
updated environmental information and to add the veal calf warning
statement to the residue
information section.
Date of Approval: April 21, 2004
NADA 140-839 original approval
Sponsor: Beecham Laboratories
Generic Name: mupirocin
Trade Name: BACTODERM®
Indications for use: BACTODERM® Ointment is indicated
for the topical treatment of canine bacterial infections of
the skin, including superficial pyoderma, caused by susceptible
strains of the following organisms: Staphylococcus aureus
and Staphylococcus intermedius.
Date of Approval: September 28, 1988
NADA 140-841
original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC Pour-On for Cattle
Indications for use: For the treatment and control of
gastrointestinal nematodes, lungworms, cattle grubs, sucking
and biting lice, and sarcoptic mange mites.
Date of Approval: August 30, 1990
NADA 140-841 supplemental
approval
Sponsor: Merck & Co.
Generic Name: ivermectin
Trade Name: Ivomec Pour-On® for Cattle
Date of Approval: June 5, 1997
NADA 140-841 supplemental
approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Ivomec (ivermectin) Pour-On for Cattle
Indications for use: For the effective treatment and
control of parasites.
Date of Approval: November 24, 2003
NADA 140-842 original approval
Sponsor: MacPage, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 2.4 Premix
Indications for use: SWINE: Control of infestations of
large roundworms, nodular worms and whipworms . CHICKENS: Control
of infestations of large roundworms, cecal worms, and capillary
worms.
Date of Approval: August 5, 1987
NADA 140-843 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: narasin, bambermycins, roxarsone
Trade Name: Monteban®, Flavomycin®, 3-Nitro®
Indications for use: To prevent coccidiosis caused by
Eimeria necatrix, E. tenella, E. acervulina,
E. brunetti, E. mivati, and E. maxima,
and for increased rate of weight gain, improved fee efficiency,
and improved pigmentation in broiler chickens.
Date of Approval: December 23, 1997
NADA 140-844 original approval
Sponsor: American Cyanamid Co.
Generic Name: levamisole
Trade Name: TRAMISOL®
Indications for use: TRAMISOL levamisole Pour-On is a
broad spectrum anthelmintic which is effective against the following
nematode infections in cattle when used in accordance with label
directions: stomach worms, intestinal worms, and lungworms.
Date of Approval: January 21, 1988
NADA 140-845 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: bambermycins, narasin
Trade Name: Flavomycin, Monteban
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by susceptible organisms and for
increased rate of weight gain and for improved feed efficiency
in broiler chickens.
Date of Approval: February 7, 1989
NADA 140-846 original approval
Sponsor: Wildlife Laboratories, Inc.
Generic Name: melatonin implant
Trade Name: PRIME-X
Indications for use: PRIME-X is recommended for use in
healthy male and female kit and adult female mink selected for
accelerated priming: PRIME-X implanted mink complete autumn
molt and prime 4-6 weeks earlier than normal.
Date of Approval: June 21, 1994
NADA 140-847 original approval
Sponsor: Altana Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton,
triamcinolone acetonide ointment
Trade Name: Animax Ointment
Indications for use: Animax Ointment (nystatin, neomycin
sulfate, thiostrepton, triamcinolone acetonide ointment) is
particularly useful in the treatment of acute and chronic otitis
of varied etiologies, in interdigital cysts in cats and dogs,
and in anal gland infections in dogs. The preparation is also
indicated in the management of dermatologic disorders characterized
by inflammation and dry or exudative dermatitis, particularly
those caused, complicated, or threatened by bacterial or candidal
infections. It is also of value in eczematous dermatitis, contact
dermatitis, and seborrheic dermatitis, and as an adjunct in
the treatment of dermatitis due to parasitic infestation.
Date of Approval: September 30, 1988
NADA 140-848 original approval
Sponsor: Hoffman-La Roche Inc.
Generic Name: diazepam
Trade Name: Veteeze® Injection
Indications for use: As a preanesthetic agent to reduce
the amount barbiturate required for short duration anesthesia
in dogs.
Date of Approval: December 17, 1992
NADA 140-850 original approval
Sponsor: Elite Chemical Corp., Inc.
Generic Name: dicholorophene-toluene worm capsules
Trade Name: Elite Dog & Cat Wormer, Elite Dog Wormer,
Elite Cat Wormer
Indications for use: For removal of ascarids and hookworms
and as an aid in removal of tapeworms from dogs and cats.
Date of Approval: February 14, 1989
NADA 140-851 original approval
Sponsor: Hess & Clark, Inc.
Generic Name: 0.2% nitrofurazone dressing (water soluble)
veterinary
Trade Name: NFZ Wound Dressing
Indications for use: For the prevention or treatment
of surface bacterial infections of wounds, burns, and cutaneous
ulcers of dogs, cats and horses (not for food use).
Date of Approval: July 7, 1989
NADA 140-852 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: narasin, roxarsone, bacitracin methylene
disalicylate
Trade Name: Monteban®, 3-Nitro®, BMD®
Indications for use: For the prevention of coccidiosis
caused by susceptible organisms and for increased rate of weight
gain and improved feed efficiency in broiler chickens.
Date of Approval: July 5, 1989
NADA 140-852 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin Bacitracin methylene disalicylate
Roxarsone
Trade Name: Monteban®, 3-Nitro®, BMD®
Date of Approval: July 29, 1998
NADA 140-853 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate, narasin
Trade Name: BMD®, Monteban®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. mivati , and E. brunetti , for increased
rate of weight gain, and for improved feed efficiency in broiler
chickens.
Date of Approval: May 22, 1992
NADA 140-854
original approval
Sponsor: Syntex Animal Health, Inc.
Generic Name: oxfendazole
Trade Name: Synanthic®
Indications for use: Oxfendazole is indicated for the
treatment and control of: lungworms, stomach worms, and intestinal
worms.
Date of Approval: September 17, 1990
NADA 140-856 supplemental
approval
Sponsor: Intervet, Inc.
Generic Name: serum gonadotropin and chorionic gonadotropin
for injection
Trade Name: P.G. 600 ®
Effect of Supplement: The original application provides
for use of P.G.600 ® in prepuberal gilts. The supplement
extends the conditions of use to include sows at weaning.
Date of Approval:August 30, 1993.
NADA 140-857 original approval
Sponsor:Norden Laboratories, Inc.
Generic Name:luprostiol
Trade Name:Equestrolin
Indications for use: Indicated for 1) estrus control
and 2) termination of pregnancy in mares.
Date of Approval: January 5, 1990
NADA 140-859 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline
Trade Name: BIO-COX® + AUREOMYCIN®
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by susceptible organisms and as an
aid in the reduction of mortality due to E. coli infections
susceptible to such treatment.
Date of Approval: June 13, 1989
NADA 140-863
original approval
Sponsor: Elanco Animal Health.
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Indications for use: For increased rate of weight gain,
improved feed efficiency, and increased carcass leaness in finishing
swine fed a complete ration containing at least 16% crude protein
from 150lbs (68kg) to 240lb (109 kg) body weight.
Date of Approval: December 22, 1999
NADA 140-863 supplemental approval
Sponsor: Elanco Animal Health.
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Effect
of Supplement: To
amend cautionary language in product labeling
Date of Approval: June 6, 2002
ADA 140-865 original approval
Sponsor: Roche Vitamins Inc.
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, BACIFERM
Indications for use: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti,
E. mivati, and E. maxima. For increased rate of weight gain
and improved feed efficiency in broiler chickens.
Date of Approval: August 7, 2000
NADA 140-865 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, ALBAC
Indications for use: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina,
E. brunetti, E. mivati, and E. maxima, and for increased rate
of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: April 29, 2002
NADA 140-866 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: yohimbine hydrochloride injectable solution
Trade Name: YobineInjectable Solution
Indications for use: Xylazine Reversing Agent and Antidote
For Use in Dogs Only
Date of Approval: September 26, 1989
NADA 140-867 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline
+ roxarsone
Trade Name: BIO-COX® + AUREOMYCIN® + 3-Nitro®
Indications for use: For the prevention of coccidiosis
in broiler chickens cause by susceptible organisms including
some field strains of E. tenella that are more susceptible
to roxarsone combined with salinomycin than salinomycin alone
as an aid in the reduction of mortality due to E. coli
infections susceptible to such treatment.
Date of Approval: June 12, 1989
NADA 140-869 original approval
Sponsor: Purina Mills, Inc.
Generic Name: medicated feed block containing 6.6% poloxalene
Trade Name: Purina Bloat Block
Indications for use: For control of legume (alfalfa,
clover) and wheat pasture bloat in cattle when consumed at the
prescribed rate.
Date of Approval: August 8, 1989
NADA 140-872
original approval
Sponsor: Animal Sciences Division of Monsanto Company
Generic Name: Recombinant DNA-derived methionyl bovine
somatotropin
Trade Name: POSILAC® (sterile sometribove zinc suspension)
Indications for use: For increased production of marketable
milk in lactating dairy cows.
Date of Approval: November 5, 1993
NADA 140-872 supplemental
approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Date of Approval: December 27, 2001
NADA 140-872 supplemental
approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Date of Approval: September 11, 2003
NADA 140-874 original approval
Sponsor: Wildlife Laboratories
Generic Name: yohimbine hydrochloride
Trade Name: Antagonil
Indications for use: For the antagonism of xylazine sedation
in free-ranging and confined members of the family Cervidae
(deer and elk).
Date of Approval:February 3, 1993
NADA 140-879 original approval
Sponsor: Norden Laboratories
Generic Name: nystatin - neomycin sulfate - thiostrepton
- triamcinolone - acetonide topical ointment
Trade Name: DERMA 4 Ointment
Indications for use: DERMA 4 Ointment is particularly
useful in the treatment of: (1) acute and chronic otitis of
varied etiologies; (2) interdigital cysts in dogs and cat; (3)
anal gland infections in dogs; (4) dermatologic disorders characterized
by inflammation and dry or exudative dermatitis, particularly
those caused, complicated, or threatened by bacterial or candidal
(Candida albicans ) infection; and (5) eczematous, contact
and seborrheic dermatitis. Additionally, DERMA 4 Ointment may
be used as an adjunct in the treatment of dermatitis due to
parasitic infestation.
Date of Approval: August 2, 1989
NADA 140-881 original approval
Sponsor: Biomed Laboratories
Generic Name: nitrofurazone soluble dressing
Trade Name: Nitrofurazone Soluble Dressing
Indications for use: For the prevention or treatment
of surface bacterial infections of wounds, burns and cutaneous
ulcers of dogs, cats and horses (not for food use).
Date of Approval: May 11, 1990
NADA 140-883 original approval
Sponsor: MOBAY Corporation
Generic Name: Hyaluronate Sodium
Trade name: Legend(TM) (Hyaluronate Sodium) Injectable
Solution
Indications for Use:
Legend Injectable Solution is indicated in the treatment of
joint dysfunction of the carpus or fetlock in horses due to
non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: September 12, 1991
NADA 140-886 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: HEARTGARD-30 Chewables
Indications for use: For use in dogs to prevent canine
heartworm disease by eliminating the tissue stage of heartworm
larvae (Dirofilaria immitis ) up to a month after infection.
Date of Approval: July 3, 1989
NADA 140-889 original approval
Sponsor: A.H. ROBINS and Biocraft Laboratories, Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton,
triamcinolone, acetonide ointment
Trade Name: Derm-Otic Ointment
Indications for use: Derm-Otic Ointment (nystatin, neomycin
sulfate, thiostrepton, triamcinolone acetonide ointment) is
particularly useful in the treatment of acute and chronic otitis
of varied etiologies, in interdigital cysts in cats and dogs,
and in anal gland infections in dogs. The preparation is also
indicated in the management of dermatologic disorders characterized
by inflammation and dry or exudative dermatitis, particularly
those caused, complicated, or threatened by bacterial or candidal
(Candida albicans ) infections. It is also of value in
eczematous dermatitis, and as an adjunct in the treatment of
dermatitis due
to parasitic infestation.
Date of Approval: November 21, 1989
NADA 140-890 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur hydrochloride sterile suspension
Trade Name: EXCENEL® Sterile Suspension*
Indications for use: EXCENEL® Sterile Suspension
is indicated for the treatment/control of swine bacterial respiratory
disease (swine bacterial pneumonia) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis
and Streptococcus suis
Type 2.
Date of Approval: April 26, 1996
NADA
140-890 (two approvals) (supplemental)
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: Excencel® Sterile Suspension
Effect of Supplement: The supplemental application dated
7/26/98 provides for the use of an intramuscular or subcutaneous
route of administration for Excenel® Sterile Suspension
in new species cattel. The application dated 08/18/98 provides
a revised label warning statement against use in veal calves.
Date of Approval: July 26, 1998; August 18, 1998
NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: This supplement provides a new
indication, within the currently approved dose and duration,
for use of ceftiofur hydrochloride sterile suspension (EXCENEL®
RTU Sterile Suspension) in cattle, for the treatment of acute
metritis (0-14 days post-partum) associated with bacterial organisms
susceptible to ceftiofur.
Date of Approval: February 8, 2002
NADA 140-890 supplemental
approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: To make the following four changes
to the product insert:
1. revise the current "Microbiology" section to a "Clinical
Microbiology" section
2. revise the minimum inhibitory concentration (MIC) table to
include new MIC data for ceftiofur
3. add a table listing acceptable quality control ranges for
ceftiofur
4. revise the National Committee for Clinical Laboratory Standards
reference at the end to the insert.
Date of Approval: December 12, 2003
NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU
Effect of Supplement: For the treatment and control of
swine bacterial respiratory disease (swine bacterial pneumonia)
associated with Actinobacillus (Haemophilus) pleuropneumoniae,
Pasteurella multocida, Salmonella choleraesuis, and Streptococcus
suis type 2.
Date of Approval: June 18, 2004
NADA 140-892 original approval
Sponsor: Syntex Animal Health
Generic Name: oxfendazole
Trade Name: Synanthic® Bovine Dewormer Paste, 18.5%
Indications for Use: Oxfendazole is indicated for use
in cattle (excluding female dairy cattle of lungworms, stomach
worms, small stomach worms, small intestinal worms, tapeworms
and nodular worms.
Date of Approval: June 29, 1993
NADA 140-893 original approval
Sponsor: Beecham Laboratories
Generic Name: Epsiprantel
Trade Name: CESTEX ®
Indications for Use: CESTEX® (epsiprantel) tablets
are indicated for the removal of the following: Feline cestodes:Dipylidium
caninumand Taenia taeniaeformis.Canine cestodes:Dipylidium
caninumand Taenia pisiformis
Date of Approval: December 1, 1989
NADA 140-896 (INAD 4521) (original
approval)
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, clotrimazole, and betamethasone
valerate
Tradename: OTOMAX®
Indications
for Use:OTOMAX is indicated for treatment of canine acute
and chronic otitis externa associated with yeast (Malassezia
pachydermatisformerly Pityrosporum canis) and/or
bacteria susceptible to gentamicin.
Date of Approval June 9, 1993
NADA 140-897
original approval
Sponsor: Roussel UCLAF
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-S
Indications for use: For increased rate of weight gain
and improved feed efficiency in feedlot steers.
Date of Approval: November 27, 1991
NADA 140-897 supplemental
approval
Sponsor: Roussel Uclaf
Generic Name:trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement:Provides for the administration
of REVALOR®-G in pasture steers (slaughter, stocker and
feeder steers) for increased rate of weight gain.
Date of Approval: March 27, 1996
NADA 140-897
supplemental approval
Sponsor: Roussel Uclaf
Generic Name:trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement:Provides for the administration
of REVALOR®-G in pasture heifers (slaughter, stocker and
feeder heifers) for increased rate of weight gain.
Date of Approval: July 2, 1996
NADA 140-897 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-IS
Effect of Supplement: Provides for the use of an additional
dose ear implant for steers fed in confinement for slaughter
for increased rate of weight gain and improved feed efficiency.
Date of Approval: June 19, 2000
NADA 140-901 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan (PSGAG)
Trade Name: Adequan® i.m.
Indications for use: Adequan® i.m. is recommended
for the intramuscular treatment of noninfectious degenerative
and/or traumatic joint dysfunction and associated lameness of
the carpal joint in horses.
Date of Approval: November 11, 1989
NADA 140-901 supplemental
approval
Sponsor:Adequan® i.m
Generic Name:Polysulfated Glycosaminoglycan (PSGAG)
Trade Name:Adequan® i.m
Effect of Supplement: Effect of Supplement: This supplemental
application amends the NADA to provide for the use of Adequan®
i.m. in the treatment of noninfectious degenerative and/or traumatic
joint dysfunction and associated lameness of the hock joint
in horses.
Date of Approval: September 12, 1996
NADA 140-904 original approval
Sponsor: Veterinary Research and Development, Inc.
Generic Name: copper disodium edetate
Trade Name: Bovi-Cu
Indications for use: For use in beef cattle and beef
calves to prevent copper deficiency alone on or in association
with molybdenum toxicity.
Date of Approval: April 18, 1989
NADA 140-908 original approval
Sponsor: Lloyd, Inc.
Generic Name: Slfamethazine
Trade Name: Veta-Meth
Indications for use: For the treatment of diseases caused
by organisms sensitive to sulfamethazine such as bacterial pneumonia
and bovine respiratory disease complex (shipping fever complex)
...
Date of Approval: September 16, 1999
NADA 140-909 original approval
Sponsor: Norden Laboratories, Inc.
Generic Name: sulfamethazine bolus
Trade Name: Sulka-S Bolus
Indications for use: For treatment of the following diseases
caused by organisms susceptible to sulfamethazine: bacterial
scours (colibacillosis) caused by Escherichia coli ,
necrotic pododermatitis (foot rot) and calf diphtheria caused
by Fusobacterium necrophorum , bacterial pneumonia associated
with Pasteurella spp. , and coccidiosis caused by Eimeria
bovis and E. zurnii in ruminating beef and dairy
calves.
Date of Approval: March 27, 1989
NADA 140-910 original approval
Sponsor: HESS & CLARK, INC.
Generic Name: nitrofurazone soluble powder
Trade Name: NFZ Wound powder
Indications for use: For the prevention or treatment
of surface bacterial infections of wounds, burns, skin ulcers
and abscesses after incision. For use only on dogs, cats and
horses (not for food use).
Date of Approval: July 17, 1989
NADA 140-912 original approval
Sponsor: Mobay Corporation
Generic Name:febantel
Trade Name: Rintal® Tabs Anthelmintic Tablets
Indications for use: Rintal® Tabs Anthelmintic Tablets
are indicated for the removal of th following nematode parasites:
In Dogs and Puppies: Hookworms (Ancylosotoma caninum, Uncinaria
stenocephala); Ascarids (Toxocara canis, Toxascaris leonina):
Whipworms (Trichuris vulpis). In Cats and Kittens: Hookworms
(ancylostoma tubaeforme); Ascarids (Toxocara cati).
Date of Approval: July 19, 1991
NADA 140-913 original approval
Sponsor: Mobay Corporation
Generic Name: Enrofloxacin
Trade Name: Baytril® Antibacterial Injectable Solution
Indications for use: Baytril® (brand of enrofloxacin)
Antibacterial Tablets and Injectable Solution are indicated
for the treatment of the following bacterial infections in dogs:
Dermal infections (wounds and abscesses) caused by susceptible
strains of Escherichia coli, Klebsiella pneumoniae
*, Proteus mirabilis, and Staphylococcus aureus;
Respiratory infections (pneumonia, tonsillitis, rhinitis) caused
by susceptible strains of Escherichia coliand Staphylococcus
aureus.
Date of Approval: May 4, 1990
140-913 supplemental approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable
solution
Trade Name: Baytril® Antibacterial Tablets and Baytril®
Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications,
and limitations.
Date of Approval: June 19, 1997
NADA 140-915 original approval
Sponsor: Ciba-Geigy Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Indications for use: Interceptor tablets are indicated
for use in the prevention of heartworm disease caused by Dirofilaria
immitis and control of adult hookworm infections caused
by Ancylostoma caninum in dogs.
Date of Approval: June 14, 1990
NADA 140-915 supplemental
approval
Sponsor:Ciba-Geigy Corporation
Generic Name:milbemycin oxime
Trade Name: Interceptor®
Effect of Supplement: This supplement expands the indications
to include the removal and control of adult roundworms Toxascaris
leonina. Laboratory data support the efficacy of the drug
against this species.
Date of Approval: Sep. 9, 1996
NADA 140-915 supplemental
approval
Sponsor: CIBA-GEIGY Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Effect of Supplement: Approval of the supplemental NADA
will change NADA No. 140-915 by adding indications for the removal
and control of adult Toxocara canis (roundworm) and Trichuris
vulpis (whipworm) infections in dogs over eight weeks of
age. Data supporting efficacy for the roundworm and whipworm
indications is contained in this supplemental NADA. The supplemental
application does not propose any changes in the formulation,
dosage forms, manufacturing procedures, recommended dosages
or treatment regiment for INTERCEPTOR (milbemycin oxime).
Date of Approval: December 29, 1992
NADA 140-915 supplemental
approval
Sponsor: Ciba-Geigy Corporation
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR Flavor Tabs
Effect of Supplement: Approval of the supplemental NADA
will change NADA No. 140-915 by adding indications for the use
of INTERCEPTOR (milbemycin oxime) Flavor Tabs in puppies four
weeks of age or greater and two pounds of body weight or greater
(from greater than eight weeks of age). The supplemental application
does not propose any changes in the formulation, dosage forms,
manufacturing procedures, recommended dosages or monthly treatment
regimen for INTERCEPTOR (milbemycin oxime) Flavor Tabs.
Date of Approval: August 16, 1995
NADA 140-915 supplemental approval
Sponsor: Novartis Animal Health
Generic Name:milbemycin oxime
Trade Name: INTERCEPTOR® FLAVOR TABS® for cats
Effect of Supplement: Approval of this supplemental NADA
will change NADA 140-915 by adding an additional species (cat)
to the label. The supplemental application also provides for
changes in the dosage and indications for the cat only. No changes
are made in the dosage form, dosages or treatment regimen for
the dog. The cat will have labeling separate from the dog approval.
Date of Approval: March 10, 1998
NADA 140-915 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin oxime
Trade Name: Safeheart
Effect of Supplement: For the prevention of heartworm
disease caused by Dirofilaria immitis in dogs and puppies
four weeks of age or greater and 2 pounds of body weight or
greater.
Date of Approval: June 4, 1998
NADA 140-916 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin
Trade Name: DENAGARD ® Liquid Concentrate
Indications for use: For the treatment of swine dysentery
associated with Treponema hyodysenteriae and swine pneumonia
due to Actinobacillus pleuropneumoniae susceptible to
tiamulin.
Date of Approval: Jan 29, 1993
NADA 140-918 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name:halofuginone hydrobromide, bambermycins
Trade Name: Stenorol®, Flavomycin®
Indications for use: For the prevention of coccidiosis
caused by Eimeria adenoeides, E. meleagrimitis, and E.
gallopavonis, and for increased rate of weight gain in growing
turkeys.
Date of Approval: March 22, 1996
NADA 140-919 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name:halofuginone hydrobromide; bacitracin methylene
disalicylate
Trade Name: Stenorol®, BMD®
Indications for use: For the prevention of coccidiosis
caused by Eimeria adenoeides, E. meleagimitis, and E.
gallopavonis; and for increased rate of weight gain in growing
turkeys.
Date of Approval: Jan 29, 1993
NADA 140-921 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: Prednisolone, USP oral tablet 5.0 mg
Trade Name: PrednisTab
Indications for Use: PrednisTab is intended for
use in dogs. The indications for PrednisTab are the same
as those for other anti-inflammatory steroids and comprise the
various collagen, dermal, allergic, ocular, otic, and musculoskeletal
conditions known to be responsive to the anti-inflammatory corticosteroids.
Date of Approval: November 8, 1991
NADA 140-921 supplemental
approval
Sponsor: Lloyd, Incorporated
Generic Name: prednisolone, USP
Trade Name: PrednisTab®
Effect of Supplement: Provides for a new 20 mg tablet
size.
Date of Approval: November 20, 1997
NADA 140-926 original approval
Sponsor: Elanco Animal Health, Division of Eli Lilly
& Co.
Generic Name: Narasin/nicarbazin (in a fixed combination),
bacitracin methylene disalicylate
Trade Name: Maxiban®/BMD®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima,
E. brunetti, and E. mivati, and for increased rate of weight
gain and improved feed efficiency.
Date of Approval: January 4, 1999
NADA 140-927 original approval
Sponsor: Intervet America, Inc.
Generic Name: chorionic gonadotropin
Trade Name: CHORULON®
Indications for use: CHORULON is indicated for the intramuscular
use in cows for the treatment of nymphomania (frequent or constant
heat) due to cystic ovaries.
Date of Approval: November 22, 1991
NADA 140-927 supplemental
approval
Sponsor: Intervet Inc.
Generic Name: chorionic gonadotropin
Trade Name: Chorulon®
Effect of Supplement: Provides for the use of chorionic
gonadotropin (Chorulonâ ) as an aid in improving spawning
function in male and female brood finfish.
Date of Approval: August 6, 1999
NADA 140-929 original approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin Phosphate
Trade Name: MICOTIL® 300
Indications For Use: For the treatment of respiratory
disease (BRD) associated with Pasteurella haemolytica in cattle.
Date of Approval: March 3, 1992
NADA 140-929
supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin injection USP
Trade Name: Micotil® 300
Effect of Supplement: Provides for the use of tilmicosin
phosphate (Micotil® 300) in cattle for a new therapeutic
claim.
Date of Approval: December 30, 1996
NADA 140-929 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: Deletes the following statements
from the label: "A withdrawal period has not been established
for this product in pre-ruminating calves. Do not use in calves
to be processed for veal."
Date of Approval: December 23, 1997
NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: This supplemental application provides
for the addition of a new species, sheep.
Date of Approval: September 4, 2002
NADA 140-934 original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: Albendazole
Trade Name: VALBAZEN®
Indications for use: For the removal and control of the
following endoparasites infecting sheep: A.Liver flukes;
B.Tapeworms; C.Lungworms; D.Stomach worms;
E.Intestinal worms
Date of Approval: November 10, 1994
NADA 140-937 original approval
Sponsor: Elanco Animal Health
Generic Names:Monensin Sodium
Bacitracin Methylene Disalicylate
Trade Name: COBAN®, and BMD®,
No Trade Name Proposed for Combination
Indications for use: For the prevention of coccidiosis
caused by Eimeria adenoeides, E. meleagrimitis, and E.
gallopavonis, and for increased rate of weight gain and
improved feed efficiency in growing turkeys.
Date of Approval: November 18, 1994
NADA 140-937 supplemental
approval
Sponsor: Elanco Animal Health
Generic Names:monensin sodium, bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Effect of Supplement: This supplemental application
provides for a new combination including bacitracin methylene
disalicylate, as an aid in the control of transmissible enteritis
complicated by susceptible organisms at a new use level, when
used in Type C medicated feeds in combination with monensin
for the prevention of coccidiosis.
Date of Approval: August 13, 1998
NADA 140-940
original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin sodium
Trade Name: AVIAX®
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by Eimeria tenella, E. acervulina,
E. maxima, E. brunetti, E. necatrix and E. mivati/mitis.
Date of Approval: March 10, 1994
NADA 140-942 original approval
Sponsor: Elanco Animal Health, A Division of Eli
Lilly & Co.
Generic Name: Narasin and nicarbazin, bambermycins
Trade Name: Maxiban® plus Flavomycin®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti,
E. mivati, and E. maxima and for increased rate of weight gain
and improved feed efficiency.
Date of Approval: March 8, 2001
NADA 140-947 original approval
Sponsor: Elanco Animal Health
Generic Name: Narasin, nicarbazin, lincomycin
Trade Name: Mexiban®, Lincomix®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina,
E. maxima, E. brunetti, and E. mivati, and
for increase in rate of weight gain and improved feed efficiency
in broiler chickens.
Date of Approval: September 3, 1998
NADA 140-951
original approval
Sponsor: Schering-Plough Aminal Health
Generic Name: Diclazuril
Trade Name: Clinacox
Indications for use: For the prevention of coccidiosis
by Eimeria tenella, E. necatrix, E. acervulina, E.
brunetti, E. mitis (E. mivati), and E. maxima.
Date of Approval: April 21, 1999
NADA
140-951
Sponsor: Schering-Plough Aminal Health
Generic Name: Diclazuril
Trade Name: Clinacox
Indications for use: Growing Turkeys: For the prevention
of coccidiosis by Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mitis (E. mivati), and E.
maxima.
Effect of Supplement: This supplement provides for the
addition of a new species, growing turkeys, to be added to the
previously approved product, CLINACOX Type A medicated
article
Date of Approval: September 21, 2001
NADA 140-954 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole, lincomycin
Trade Name: Safe-Guard®, Type "A" Medicated
Article (Premix)
Indications for use: Fenbendazole is indicated for the
removal of: LUNGWORMS; GASTROINTESTINAL WORMS; KIDNEYWORMS ...
Date of Approval: July 9, 1992
NADA 140-955 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Bambermycin
Trade Name:COBAN®, FLAVOMYCIN®
Indications for use: For the prevention of coccidiosis
caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis,
and for increased rate of weight gain and improved feed efficiency
in growing turkeys.
Date of Approval: June 28 2000
NADA 140-958 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: phenylbutazone paste
Trade Name: Equiphen Paste
Indications for use: For relief of inflammatory conditions
associated with the musculoskeletal system in horses.
Date of Approval: May 14, 1993
NADA 140-971 original approval
Sponsor: Merck Research Laboratories
Generic Name:ivermectin and pyrantel (as pamoate salt)
Trade Name:HEARTGARD-30® Plus
Indications for use: To prevent canine heartworm disease
by eliminating the tissue larval stages of Dirofilaria immitis
for a month (30 days) after infection), pyrantel pamoate
(for the treatment and control of adult Toxocara canis, Toxascaris
leonina, Ancylostoma caninum and Uncinaria stenocephala
in dogs.
Date of Approval:January 15, 1993
NADA 140-971 supplemental
approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin; pyrantel (as pamoate salt)
Trade Name: Heartgard Plus
Effect of Supplement: This supplement expands the indications
to include the treatment and control of adult hookworms (Ancylostoma
braziliense).
Date of Approval: October 3, 1996
NADA 140-973 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: clenbuterol hydrochloride
Trade Name: VENTIPULMIN® SYRUP
Indications for use: Ventipulmin® Syrup
(clenbuterol hydrochloride) is indicated for use in the management
of horses affected with airway obstruction, such as occurs in
chronic obstructive pulmonary disease (COPD).
Date of Approval: May 11, 1998
NADA 140-974
original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine
Indications for use: For the treatment and control of
GASTROINTESTINAL ROUNDWORMS; KIDNEYWORMS ; LUNGWORMS when incorporated
into complete swine feeds.
Date of Approval: September 23, 1993
NADA 140-974 supplemental
approval
Sponsor: Merck Research Laboratoriesf
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine;
Effect of Supplement: To add the label claim for treatment
of breeding swine.
Date of Approval: July 27, 1995
NADA 140-974 supplemental
approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine;
Effect of Supplement: Provides for a new claim for the
treatment and control of threadworms and use of Type C medicated
feed as a top-dressing for adult swine.
Date of Approval: August 10, 1998
NADA 140-976 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: neomycin sulfate
Trade Name: Neomix® 325 Medicated Premix / Neomix®
AG 325 Medicated Premix
Effect of Supplement: Provides for the finalization of
NAS/NRC/DESI review of Neomycin Sulfate Type A Medicated Articles.
Date of Approval: November 3, 1999
NADA 140-988
original approval
Sponsor: Merck Research Laboratories
Generic Name:ivermectin
Trade Name: Ivomec® SR Bolus for Cattle
Indications for use: The Ivomec® SR Bolus is indicated
for (1) the treatment of established infections and, throughout
its approximately 135-day invermectin delivery period, prevents
the establishment of infection by newly ingested larvae of certain
nematode species, (2) treatment of established infections of
certain mange mites, (3) treatment of established infections
of certain sucking lice, (4) control of existing Hypoderma
larvae or grubs and newly acquired larvae during the 135-day
period, and (5) control of the tick Amblyomma americanum
by interfering with engorgement with blood and completion of
the reproductive portion of the young adult female life cycle.
Date of Approval: November 18, 1996
NADA 140-988 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec® SR Bolus for Cattle
Effect
of Supplement: Provides for reducing the predicted duration
of effectiveness from "approximately 135 days" to
"approximately 130 days".
Date of Approval: June 21, 2000
NADA 140-989 original approval
Sponsor: Western Chemical, Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Indications for use: A. Formalin is indicated for the
control of external parasites on cultured food fishes: salmon,
trout, catfish, largemouth bass, and bluegill sunfish. Organisms
controlled include the protozoa: Ichthyophthirius spp.
("Ich"), Chilodonella spp., Costia spp.,
Scyphidia spp., Epistylis spp., and Trichodina
spp. and monogenetic trematodes: Cleidodiscus spp., Gyrodactylus
spp., and Dactylogyrus spp.; B. For control of fungi
of the family Saprolegniaceae on salmon, trout, and esocid eggs.
Date of Approval: July 31, 1992
NADA 140-989 supplemental
approval
Sponsor: Western Chemical Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Effect of Supplement:To add a new species, new claims,
new dosages, and new treatment regimens.
Date of Approval: September 30, 1993
NADA 140-989
supplemental approval
Sponsor:Western Chemical, Inc.
Generic Name:Formalin
Trade Name: Parasite-S
Date of Approval: June 18, 1998
NADA 140-992
original approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: Revalor®-H
Indications for use: For increased rate of weight gain
and improved feed efficiency in heifers fed in confinement for
slaughter.
Date of Approval: December 13, 1994
NADA 140-992 supplemental
approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Summary: This supplemental application provides
for the use of a higher dose ear implant for steers fed in confinement
for slaughter for increased rate of weight gain and improved
feed efficiency.
Date of Approval: November 29, 1999
NADA 140-992 supplemental
approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-IH
Effect of Summary: This supplemental application provides
for the use of an additional dose ear implant for heifers fed
in confinement for slaughter for increased rate of weight gain
and improved feed efficiency.
Date of Approval: June 19, 2000
NADA 140-992 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Summary: Provides for the administration of
REVALOR®-200
to heifers fed in confinement for slaughter.
Date of Approval: December 6, 2001
NADA 140-994 original approval
Sponsor: Lloyd, Inc.
Generic Name:Tolazoline Hydrochloride, USP, Sterile Solution
Trade Name: TolazineInjection
Indications for use: Tolazine should be used in horses
when it is desirable to reverse the effects of sedation and
analgesia caused by xylazine.
Date of Approval: April 19, 1996
NADA 140-998
original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: virginiamycin
Trade Name: V-Max
Indications for use: For increased rate of weight gain,
for improved feed efficiency, and for reduction in the incidence
of liver abscesses in cattle fed in confinement for slaughter.
Date of Approval: June 24, 1994
NADA 140-999 original approval
Sponsor: Orion Corporation
Generic Name:medetomidine hydrochloride
Trade Name: Domitor®
Indications for use: Domitor is indicated for use as
a sedative and analgesic in dogs over 12 weeks of age, to facilitate
clinical examinations, clinical procedures, minor surgical procedures
not requiring muscle relaxation, and minor dental procedures
not requiring intubation. The IV route of administration is
more efficacious for dental care.
Date of Approval: March 19, 1996
ANADA 141-002 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Oxytetracycline HCL
Trade Name: OXY 500 Claf Bolus / OXY 1000 Calf Bolus
Indications for use: For the control and treatment of
the following diseases caused by organisms sensitive to oxytetracycline;
bacterial entertis caused by Salmonella typhimurium and Escherichia
coli (colibacillosis); bacterial pneumonia (shipping fever
complex, pasteurellosis) caused by Pasteurella multocida.
Date of Approval: October 26, 1998
NADA 141-007 original approval
Sponsor: Miles, Inc.
Generic Name: praziquantel + pyrantel Pamoate + febantel
Trade Name: Drontal Plus Broad Spectrum Anthelmintic
Tablets
Indications for use: Drontal Plus Broad Spectrum
Anthelmintic Tablets are indicated for the removal of tapeworms,
hookworms, ascarids, whipworms in dogs.
Date of Approval: May 19, 1994
NADA 141-007 supplemental
approval
Sponsor: Bayer Corporation
Generic Name:Praziquantel + Pyrantel Pamoate + Febantel
Trade Name:Drontal Plus Broad Spectrum Anthelmintic
Tablets
Effect of Supplement: This supplemental application amends
NADA 141-007, Drontal Plus Broad Spectrum Anthelmintic
Tablets, by adding the tape-worm Echinococcus multilocularis
claim to the label.
Date of Approval: March 28, 1996
NADA 141-007 supplemental
approval
Sponsor: Bayer Corporation Agricultural Division
Generic Name:Praziquantel + Pyrantel Pamoate + Febantel
Trade Name:Drontal Plus Broad Spectrum Anthelmintic
Tablets
Effect of Supplement: Effect of Supplement: This supplement
amends the NADA to provide for a larger tablet containing 136.0
mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate
and 680.4 mg febantel and the associated label changes.
Date of Approval: February 10, 2003
NADA 141-014 original approval
Sponsor: Ausa International Inc.
Established Name: Follicle stimulating hormone (FSH)
Trade Name: SUPER-OV®
Indications For Use: SUPER-OV® is indicated for the
induction of superovulation in cows for procedures requiring
the production of multiple ova at a single estrus. SUPER-OV®
is effective only in cows that are not pregnant and have a normal
corpus luteum, i.e. those cows that are cycling normally.
Date of Approval: August 13, 1993
NADA 141-017 original approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: Saraflox® WSP
Indications for use: Saraflox® WSPis indicated in
growing broiler chickens and growing turkeys for the control
of mortality associated with E. coli organisms sensitive
to sarafloxacin hydrochloride.
Date of Approval: August 18, 1995
NADA 141-018 original approval
Sponsor: Abbott Laboratories
Generic Name:sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Indications for use: SaraFlox® Injection is indicated
for control of early mortality associated with Escherichia
coli (colibacillosis) susceptible to sarafloxacin in day-old
broiler chickens.
Date of Approval: March 28, 1996
NADA 141-018 supplemental
approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Effect of Supplement: This supplement provides for the
addition of a new dose for in ovo administration to 18-day
embryonated broiler eggs, to be added to the previously approved
product, SaraFlox® Injection.
Date of Approval: January 21, 1997
NADA 141-025
original approval
Sponsor: Syntex Animal Health
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Indications for use: For increased rate of weight gain
and improved feed efficiency of cattle fed in confinement for
slaughter.
Date of Approval: March 4, 1994
NADA 141-025 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Indications for use: 1) For improved feed efficiency
and increased rate of weight gain in cattle fed in confinement
for slaughter. 2) For improved feed efficiency in cattle fed
in confinement for slaughter.
Date of Approval: May 12, 2003
NADA 141-026 original approval
Sponsor: Ciba Animal Health
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Indications for use: Program® Suspension is indicated
for use in cats, six weeks of age and older, for the control
of flea populations.
Date of Approval: March 28, 1995
NADA 141-026 supplemental
approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Effect of Supplement: Change from Rx to Over the Counter
and addition of an Adverse Reactions section to the product
label.
Date of Approval: December 31, 1996
NADA 141-029 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: desoxycorticosterone pivalate
Trade Name: Percorten-V
Indications for use: For use as a replacement therapy
for the mineralocoricoid dificit in dogs with primary adrenocortical
insufficiency.
Date of Approval: January 12, 1998
NADA 141-033 original approval
Sponsor:Pfizer
Generic Name:atipamezole hydrochloride
Trade Name:Antisedan®
Indications for use: ANTISEDAN ® is indicated for
the reversal of the clinical effects of the sedative and analgesic
agent, DOMITOR® (medetomidine hydrochloride), in dogs.
Date of Approval:August 6, 1996
NADA 141-034 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin®
Effect of Supplement: A previous approval (58 FR 54286;
October 21, 1993) provided for the use of bambermycins in complete
feeds for increased rate of weight gain and improved feed efficiency
of cattle fed in confinement for slaughter. This approval provides
for the same dosage range of 10 to 20 mg bambermycins/head/day
for increased rate of weight gain in pasture cattle (slaughter,
stocker and feeder cattle) when fed daily in a least one pound
of supplemental feed (Type C Medicated feed).
Date of Approval: March 14, 1994
NADA 141-034 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Gainpro
Effect of Supplement: 21 CFR 558.95 currently provides
for the use of bambermycins in cattle fed in confinement for
slaughter for improved feed efficiency and increased rate of
weight gain, and for increased rate of weight gain in pasture
cattle. This supplement provides for use of a generic formulation
of loose mineral free-choice Type C medicated feed for free-choice
supplementation to pasture cattle.
Date of Approval: July 9, 1996
NADA 141-034 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name:Bambermycins
Trade Name:GAINPRO
Date of Approval: March 10, 1998
NADA 141-034 supplemental
approval
Sponsor: Hoechst Roussel Vet
Generic Name:Bambermycins
Trade Name:GAINPRO
Date of Approval: June 29, 1998
NADA 141-034 supplemental
approval
Sponsor: Intervet, Inc.
Generic Name: Bambermycins
Trade Name:GAINPRO
Effect of Supplement: To provide for free-choice and hand-fed
consumption of bambermycins at a rate of not less than 10 mg
nor more than 40 mg per head per day to increase rate of weight
gain in pasture cattle.
Date of Approval: February 10, 2003
NADA 141-035 original approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: PROGRAM® Tablets
Indications for use: PROGRAM Tablets are indicated for
use in dogs, six weeks of age and older, for the prevention
and control of flea populations.
Date of Approval: November 23, 1994
NADA 141-035 supplemental
approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: Program® Tablets
Effect of Supplement: Change from Rx to Over the Counter
and addition of an Adverse Reactions section to the product
label.
Date of Approval: December 31, 1996
NADA 141-035 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Tabs
Effect of Supplement: Approval of the supplemental NADA
will change NADA 141-035 by adding the indication for the use
of lufenuron tablets in cats and kittens, six weeks of age or
older, at a minimum dose of 30 mg/kg for the control of flea
populations. The cat [sic] will have labeling separate from
the original dog approval.
Date of Approval: January 23, 1997
NADA 141-035 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron
Trade Name: Program® Flavor Tabs
Effect of Supplement: This supplemental provides for
adding a flavored tablet formulation with the same indications
as the non-flavored tablets.
Date of Approval: August 1, 1998
NADA 141-035 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron
Trade Name: Program® Flavor Tabs
Effect of Supplement:This supplemental application provides
for labeling changes reflecting the concurrent use with Capstar®
(nitenpyram) Tablets (NADA 141-175) and reflecting a decrease
in the minimum age from 6 weeks to 4 weeks.
Date of Approval: June 11, 2003
NADA 141-036
original approval
Sponsor: The Upjohn Company
Generic Name: pirlimycin hydrochloride aqueous gel
Trade Name: Pirsue Aqueous Gel
Indications for use: Pirlimycin is indicated for the
treatment of clinical and subclinical mastitis in lactating
dairy cattle. Pirlimycin has been proven effective only against
Staphylococcus species such as Staphylococcus aureus
and Streptococcus species such as Streptococcus agalactiae,
Stretococcus dysgalactiae, and Streptococcus uberis.
Cows with systemic clinical signs caused by mastitis should
receive other appropriate therapy under the direction of a licensed
veterinarian.
Date of Approval: September 10, 1993
NADA 141-036 supplemental approval
Sponsor: The Upjohn Company
Generic Name: pirlimycin hydrochloride
Trade Name: PIRSUE® Sterile Solution
Effect of Supplemement: Provides for a new sterile formulation
with the same therapeutic claims. Also, provides for an Acceptable
Daily Intake, a tolerance in cattle muscle, and a 9-day pre-slaughter
withdrawal period.
Date of Approval: September 7, 2000
NADA 141-038 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: polysulfated glycosaminoglycan (PSGAG)
Trade Name: Adequan® Canine
Indications for use: Intramuscular injection for the
control of signs associated with non-infectious degenerative
and/or traumatic arthritis of canine synovial joints.
Date of Approval: July 15, 1997
NADA 141-040 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™
Indications for use: For increased rate of weight gain
and improved feed efficiency in steers and in heifers which
will not be used for reproduction.
Date of Approval: June 25, 2003
NADA 141-041 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™ C
Indications for use: For increased rate of weight gain
in calves at least 30 days old which will not be used for reproduction
and not used for veal.
Date of Approval: June 25, 2003
NADA 141-043
original approval
Sponsor: Syntex Animal Health, Division of Syntex Agribusiness,
Inc.
Generic Name:trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Indications for use: For improved feed efficiency in
steers fed in confinement for slaughter.
Date of Approval: February 22, 1996
NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of American
Home Products Corp.
Generic Name:Trenbolone acetate, estradiol benzoate
Trade Name: Synovex® Plus
Effect of Summary: provides for implanatation in steers
fed in confinement for slaughter for increased rate of weight
gain and the establishment of an ADI for trenbolone.
Date of Approval:March 16, 1999
NADA 141-043 supplemental
approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name:Trenbolone acetate, estradiol benzoate
Trade Name: Synovex® Choice
Effect of Summary: provides for use at an additional
dosing level.
Date of Approval: October 3, 2002
NADA 141-044 original approval
Sponsor: Peptech Animal Health Pty, Limited
Generic Name:Deslorelin Acetate
Trade Name: Ovuplant
Indications for use: For inducing ovulation within 48
hours in estrous mares with an ovarian follicle greater than
30 mm in diameter.
Date of Approval: June 18, 1998
NADA 141-047 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: butorphanol
Trade Name: Torbugesic-SA (butorphanol) Veterinary Injection
Indications for use: Torbugesic-SA (butorphanol tartrate,
USP) is indicated for the relief of pain in cats caused by major
or minor trauma, or pain associated with surgical procedures.
Date of Approval: July 5, 1994
NADA 141-051 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin heartworm prevention tablets
Trade Name: ProHeart for Dogs
Indications for use: To prevent infections by the canine
heartworm, Dilofilaria immitis, and the subsequent development
of canine heartworm disease.
Date of Approval: May 27, 1997
NADA 141-052 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: 0.2% cyclosporine opthalmic ointment
Trade Name: Optimmune® Opthalmic Ointment
Indications for use: For the treatment of chronic keratoconjunctivitis
sicca (KCS) in dogs.
Date of Approval: August 2, 1995
NADA 141-052 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: 0.2% cyclosporine USP ophthalmic ointment
Trade Name: Optimmune® ophthalmic ointment
Effect of Supplement: To add the label claim for the
management of chronic superficial keratitis (CSK) in dogs. In
addition, the label claim for treatment of chronic keratoconjunctivis
sicca (KCS) was changed to management of chronic KCS. The term
management reflects the complexity of therapy for the two diseases.
Date of Approval: August 26, 1997
NADA 141-053 original approval
Sponsor: Pfizer Inc.
Generic Name:carprofen
Trade Name: Rimadyl®
Indications for use: RIMADYL® is indicated for the
relief of pain and inflammation in dogs. RIMADYL was shown to
be clinically effective for the reflief of signs associated
with osteoarthritis in dogs.
Date of Approval: October 25, 1996
NADA 141-053
Sponsor: Pfizer Inc.
Generic Name:carprofen
Trade Name: Rimadyl® Caplets
Indications for use: Rimadyl® is indicated for the
relief of pain and inflammation associated with osteoarthritis
in dogs.
Effect of Supplement:This supplement provides for flexibility
in administration of the total daily dose of Rimadyl® caplets.
The drug may be administered orally at 2 milligrams per pound
of body weight once daily or 1 milligram per pound of body weight
twice daily.
Date of Approval: September 27, 2001
NADA 141-054 original approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin and lincomycin
Trade Name: IVOMEC® Premix for Swine, Type A Medicated
Article and LINCOMIX® Premix, Type A Medicated Article
Indications for use: Ivermectin: For the treatment and
control of gastrointestinal roundworms, kidneyworms, lungworms,
lice and mange mites in swine. Lincomycin: for increased rate
of weight gain, for treatment and control of swine dysentery,
and for reduction in the severity of swine mycoplasmal pneumonia
caused by Mycoplasma hyopneumoniae in swine.
Date of Approval: March 28, 1996
NADA 141-059 original approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate, chlortetracycline
Trade Name: BMD®-25, BMD®-30, BMD®-40, BMD®--50,
BMD®-60, or BMD®-75 and CTC®50, CTC®65, CTC®70,
or Micro-CTC®100
Indications for use: Bacitracin methylene disalicylate
Type A Medicated Articles (NADA 46-592): For increased rate
of weight gain and improved feed efficiency. Chlortetracycline
Type A Medicated Articles (NADA 46-699): For treatmentof bacterial
enteritis caused by Escherichia coli and Salmonella
choleraesuis, and bacterial pneumonia caused by Pasteurella
multocida susceptible to chlortetracycline.
Date of Approval: September 18, 1996
NADA 141-059 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate chlortetracycline
Trade Name: BMD®10 BMD®25, BMD®30, BMD®40,
BMD®50, BMD®60, or BMD®75 and CTC®50, CTC®65,
CTC®70 Type A Medicated Articles
Date of Approval: June 24, 1998
NADA 141-059 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: chlortetracycline (CTC), bacitracin methylene
disalicylate (BMD)
Trade Name: ChlorMaxä 50, ChlorMaxä 65, or ChlorMaxä
70 and BMDâ -25, BMDâ -30, BMDâ -40, BMDâ -50, BMDâ -60 or BMDâ
-75 Type A Medicated Articles
Date of Approval: July 7, 2000
NADA 141-060 original approval
Sponsor: Novartis Alpharma, Inc.
Generic Name: Decoquinate
Trade Name: Deccox® -M Medicated Powder
for Whole Milk
Indications for use: DECCOX®-M is indicated for the
prevention of coccidiosis caused by Eimeria bovis and
E. zuernii in ruminating and non-ruminating calves, including
veal calves.
Date of Approval: January 14, 1999
NADA 141-061
original approval
Sponsor: Pfizer Inc.
Generic Name:Doramectin 1% injectable solution
Trade Name: Dectomex® Injectable Solution
Indications for use: For the treatment and control of
certain nematode and arthropod parasites in cattle.
Date of Approval: July 30, 1996
NADA 141-061 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: New claims for persistent ocntrol
of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: July 18, 1997
NADA 141-061
supplemental approval
Sponsor: Pfizer Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: Adds swine to the previously approved
NADA.
Date of Approval: September 18, 1997
NADA 141-061 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution
For Cattle and Swine
Effect of Supplement: Provides for the addition of persistent
efficacy to protect cattle from reinfection with Cooperia oncophora
for 14 days and Oesophagostomum radiatum for 28 days after treatment.
Date of Approval: October 25, 1998
NADA 141-061 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution
For Cattle and Swine
Effect of Supplement: New indication for persistent control
of nematodes in cattle adding protection against Haemonchus
placei for 14 days after treatment.
Date of Approval: February 1, 1999
NADA 141-062 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Flavor Tabs
Indications for use: Program Cat Flavor Tabs are indicated
for use in cats and kittens, six weeks of age and older, for
the control of flea populations.
Date of Approval: March 3, 1997
NADA 141-063
original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Indications for use: For the treatment of bovine respiratory
disease (BRD) associated with Pasteurella haemolytica, Pasteurella
multocida,and Haemophilus somnus.
Date of Approval: May 31, 1996
NADA 141-063 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Date of Approval: April 2, 1998
NADA 141-063 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Date of Approval: June 4, 1998
NADA 141-063 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution I
Effect of Supplement: Provides for the use
of florfenicol (Nuflorâ Injectable Solution) as a single
subcutaneous injection in cattle at high risk of developing
bovine respiratory disease (BRD).
Date of Approval: December 17, 1998
NADA 141-063 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of florfenicol
(Nuflorâ Injectable Solution) for treatment of bovine
interdigital phlegmon (foot rot, acute interdigital necrobacillosis,
infectious pododermatitis) associated with Fusobacterium
necrophorum and Bacteroides melaninogenicus.
Date of Approval: January 14, 1999
NADA 141-064
original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
and Company
Generic Name:tilmicosin phosphate
Trade Name: Pulmotil® 90
Indications for use: Pulmotil® 90 is indicated for
the control of swine respiratory disease associated with Actinobacillus
pleuropneumoniae and Pasteurella multocida.
Date of Approval: December 17, 1996
NADA 141-064 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90 Type A Medicated Article
Indications for use: Pulmotil ® 90 is indicated for
the control of swine respiratory disease associated with Actinobacillus
pleuropneumoniae and Pasteurella multocida.
Date of Approval: February 2, 1999
NADA 141-064 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90
Effect of Supplement: Changes to the label are 1) removal
of the MIC chart; 2) additions to the Pharmacology section of
the label; 3) additional CAUTION that discourages continuous
use for more than 21 days and limits use of each VFD form to
90 days. Changes to the VFD are inclusion of the additional
CAUTION like the label and 2) addition of a 90-day maximum for
the expiration of the VFD.
Date of Approval: November 15, 2001
NADA 141-065 original approval
Sponsor: Pfizer Inc.
Generic Name:Semduramicin, Bacitracin methylene disalicylate
Trade Name: Aviax , BMD®
Indications for use: For the prevention of coccidiosis
caused by Eimeria acervulina, E. brunetti, E. maxima, E.
mivati/mitis, E. necatrix, and E. tenella, and for
improved feed efficiency in broiler chickens.
Date of Approval: October 18, 1996
NADA 141-066 original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin, roxarsone
Trade Name: Aviax, 3-Nitro®
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by Eimeria acervulina, E.
brunetti, E. mivati/mitis, E. necatrix, including
some field strains of E. tenella that are more susceptible
to semduramicin combined with roxarsone than semduramicin alone.
Date of Approval: November 7, 1997
NADA 141-067 original approval
Sponsor: Biopure Corporation
Generic Name:Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin
Indications for use:Oxyglobin is indicated for the treatment
of anemia in dogs by increasing systemic oxygen content (plasma
hemoglobin concentration) and improving the clinical signs associated
with anemia for at least 24 hours, regardless of the cause of
anemia (hemolysis, blood loss, or ineffective erythropoiesis).
Date of Approval: January 12, 1998
NADA 141-067 supplemental
approval
Sponsor Name: Biopure Corporation
Generic Name: Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin® Solution
Effect of Supplement: This supplement changes the original
approval from a fixed dosage of 30 mL/kg to a flexible dosage
range of 10-30 mL/kg.
Date of Approval: January 11, 2000
NADA 141-068 original approval
Sponsor: Bayer Corporation, Agriculture Division, Animal
Health
Generic Name: Enrofloxacin
Trade Name: Baytril 100 Injectable Solution
Indications for use: For the treatment of bovine respiratory
disease (BRD) associated with Pasteurella haemolytica, Pasteurella
multocida, and Haemophilus somnus.
Date of Approval: July 24, 1998
NADA141-069
original approval
Sponsor: Alpharma, Inc.
Generic Name:colistimethate sodium
Trade Name: FIRST GUARD STERILE POWDER
Indications for use: FIRST GUARD STERILE POWDER (colistimethate
sodium) is indicated for use in 1- to 3- day-old chickens for
the control of early mortality associated with Escherichia
coli susceptible to colistin.
Date of Approval: January 13, 1998
NADA 141-070 original approval
Sponsor: Mallinkrodt Veterinary, Inc.
Generic Name:propofol
Trade Name: Rapinovet®
Indications for use: Rapinovet®is an anesthetic injection
for use in dogs as follows: a) as a single injection to provide
general anesthesia for procedures lasting up to five minutes;
b) for induction and maintenance of general anesthesia using
incremental doses to effect; and c) for induction of general
anesthesia where maintenance is provided by inhalant anesthetics.
Date of Approval: November 7, 1996
NADA 141-070 supplemental
approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name:propofol
Trade Name: Rapinovet®
Date of Approval: January 14, 1999
NADA 141-071 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: imidocarb dipropionate
Trade Name: Imizol®
Indications for use: For the treatment of babesiosis
in dogs with clinical signs and/or demonstrated Babesia
organisms in the blood.
Date of Approval: November 7, 1997
NADA 141-074
original approval
Sponsor: Wildlife Laboratories, Incorporated
Generic Name: naltrexone hydrochloride
Trade Name: Trexonil
Indications for use: For use as an antagonist to carfentanil
citrate immobilization in free-ranging or confined elk and moose
(Cervidae).
Date of Approval: December 23, 1996
NADA 141-075 original approval
Sponsor: Orphan Medical, Inc.
Generic Name:fomepizole
Trade Name: Antizol-Vet (fomepizole) for injection
Indications for use: Antizol-Vet is indicated as
an antidote for ethylene glycol (antifreeze) poisoning in dogs
who have ingested or are suspected of having ingested ethylene
glycol.
Date of Approval: November 25, 1996
NADA 141-077
original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: spectinomycin sulfate tetrahydrate
Trade Name: ADSPEC Sterile Solution
Indications for Use: ADSPEC Sterile Solution is
indicated for the treatment of bovine respiratory disease (pneumonia)
associated with Pasteurella haemolytica, Pasteurella multocida
and Haemophilus somnus.
Date of Approval: January 28, 1998
NADA 141-078 original approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin
Trade Name: Heartgard® for Cats
Indications for use: Heartgard® for Cats is indicated
for the prevention of feline heartworm disease by eliminating
the tissue stage of heartworm larvae (Dirofilaria immitis)
for a month (30 days) after infection, and for the removal and
control of adult and immature (L4) hookworms (Ancylostoma
tubaeforme and A. braziliense).
Date of Approval: December 23, 1996
NADA 141-079
original approval
Sponsor: Merck Research Laboratories
Generic Name: eprinomectin
Trade Name: Ivomec® Eprinex Pour-On
Indications for use: For treatment and control of certain
gastrointestinal nematodes, lungworms, cattle grubs, lice, mange
mites, and flies.
Date of Approval: April 16, 1997
NADA 141-079 supplemantal
approval
Sponsor: Merial Ltd.
Generic Name: Eprinomectin
Trade Name: Ivomec® Eprinex Pour-On for Beef
and Dairy Cattle
Date of Approval: August 9, 1998
NADA 141-080 original approval
Sponsor: Deprenyl Animal Health, Inc.
Generic Name: selegiline hydrochloride, the levorotatory
form of deprenyl HCl
Trade Name: Anipryl®
Indications for use: For the control of clinical signs
associated with uncomplicated canine pituitary dependent hyperadrenocorticism
(PDH).
Date of Approval: May 30, 1997
NADA 141-080 supplemental approval
Sponsor:Pfizer, Inc.
Generic Name: Seligiline hydrochloride
Trade Name: Anipryl®
Effect of Supplement: Provides for the addition of a
new claim for the clinical signs associated with canine Cognitive
Dysfunction Syndrome at a new dose of 0.5-1.0mg/kg.
Date of Approval:December 10, 1998.
NADA 141-081 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: orbifloxacin
Trade Name: Orbax
Indications for use: For the management of diseases in
dogs associated with bacteria susceptible to orbifloxacin; clinical
efficacy was established in skin and soft tissue infections
(wounds and abscesses) and urinary tract infections (cystitis)
associated with bacteria susceptible to orbifloxacin.
Date of Approval: April 22, 1997
NADA 141-081 supplemental
approval
Sponsor: Schering-Plough Animal Health
Generic Name: orbifloxacin tablets
Trade Name: Orbax tablets
Effect of Supplement: Adds cats to usage.
Date of Approval: September 18, 1997
NADA 141-082 original approval
Sponsor: Heska Corporation
Generic Name: doxycycline hyclate
Trade Name: Heska Periodontal Disease
Therapeutic
Indications for use: The Heska Periodontal Disease Therapeutic
is indicated for the treatment and control of periodontal disease
in dogs.
Date of Approval: November 19, 1997
NADA 141-083 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, bacitracin zinc
Trade Name: Avatec® plus Baciferm®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E.
brunetti, E. mivati, and E. maxima, and for increased
rate of weight gain and improved feed efficiency.
Date of Approval: April 18, 2001
NADA 141-084 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel Tablets
Indications for use: For use in dogs and puppies four
weeks of age and older and two pounds body weight or greater,
for the prevention of heartworm disease caused by Dirofilaria
immitis, for the prevention and control of flea populations,
the control of adult Ancylostoma caninum (hookworm),
and the removal and control of adult Toxocara canis,
Toxocaris lenina (roundworm) and Trichuris vulpis
(whipworm) infections.
Date of Approval: April 10, 1997
NADA 141-084 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel Flavor Tablets®
Date of Approval: June 17, 1998
NADA 141-084 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel Flavor Tablets®
Date of Approval: June 11, 2003
NADA 141-085 original approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: ZOAMIX®,BMD®
Indication for use: For the prevention and control of coccidiosis,
for increased weight gain, and improved feed efficiency in growing
turkeys.
Date of Approval: June 3, 1998
NADA 141-085 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: Zoamix® , BMD®
Effect of Supplement: provides
for using approved single ingredient bacitracin methylene disalicylate
and zoalene Type A medicated articles to make two-way combination
drug Type C medicated feeds used for the management of necrotic
enteritis and coccidiosis in replacement and broiler chickens.
Date of Approval: November 20, 2001
NADA 141-087 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: Quest moxidectin 2% Equine
Oral Gel
Indications for use: Quest moxidectin
2% Equine Oral Gel, when administered at the recommended dose
level of 0.4 mg moxidectin/kg (2.2 lb) body weight, has been
demonstrated to be effective in the treatment and control of
certain stages of gastrointestinal parasites of horses and ponies.
Date of Approval: July 11, 1997
NADA
141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of American
Home Products
Generic Name: moxidectin
Trade Name: Quest 2% Equine Oral Gel
Effect of Supplement: For treatment and control of the
following stages of gastrointestinal parasites in horses and
ponies not used for food.
Date of Approval: October 4, 1999
NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of American
Home Products
Generic Name: moxidectin
Trade Name: Quest 2% Equine Oral Gel
Effect of Supplement: For treatment and control of the
following stages of gastrointestinal parasites in horses and
ponies not used for food.
Date of Approval: October 4, 1999
NADA 141-087 supplemental
approval
Sponsor: Fort Dodge Animal Health Division of American
Home Products
Generic Name: moxidectin
Trade Name: Quest Gel
Effect of Supplement: For treatment and control of the
following stages of gastrointestinal parasites in horses and
ponies not used for food.
Date of Approval: May 29, 2003
NADA 141-087 supplemental
approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: Quest® Gel
Indications for use: For the treatment and control of
the following stages of gastrointestinal parasites of horses
and ponies six months of age and older which will not to be
used for food: Large strongyles: Strongylus vulgaris (adult
and L4/L5 arterial stages), Strongylus edentatus (adult and
tissue stages), Triodontophorus brevicauda (adults), Triodontophorus
serratus (adults) Small strongyles (adults): Cyathostomum spp.
including C. catinatum, C. pateratum; Cylicocyclus spp. including
C. insigne, C. leptostomum, C. nassatus; Cylicostephanus spp.
including C.calicatus, C. goldi, C. longibursatus, C. minutis;
Coronocyclus spp., including C. coronatus, C. labiatus, C. labratus;
Gyalocephalus capitatus; undifferentiated luminal larvae Encysted
cyathostomes: late L3 and L4 mucosal cyathostome larvae Ascarids:
Parascaris equorum (adults and L4 larval stages) Pinworms: Oxyuris
equi (adults and L4 larval stages) Hairworms: Trichostrongylus
axei (adults) Large-mouth stomach worms: Habronema muscae (adults)
Horse stomach bots: Gasterophilus intestinalis (2nd and 3rd
instars), G. nasalis (3rd instars) One dose also suppresses
strongyles egg production for 84 days.
Date of Approval: March 17, 2004
NADA 141-088 original approval
Sponsor: Alpharma, Inc.
Generic Name: Nitarsone, Bacitracin methylene disalicylate
Trade Name: HISTOSTAT®, BMD®
Indications for use: As an aid in the prevention of blackhead,
for increased weight gain, and improved feed efficiency ingrowing
turkeys.
Date of Approval: June 17, 1998
NADA 141-090 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril; Virginiamycin
Trade Name:Clinacox , Stafac®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E.
brunetti, E. mitis (mivati), and E. maxima. Because
diclazuril is effective against E. maxima later in its life
cycle, subclinical intestinal lesions may be present for a short
time after infection. Diclazuril was shown in studies to reduce
lesion scores and improve performance and health of birds challenged
with E. maxima. For increased rate of weight gain and improved
feed efficiency in broiler chickens.
Date of Approval: January 13, 2000
NADA 141-095
original approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 0.5% pour-on solution
Trade Name: Dectomax® Pour-On solution
Indications for use: To control infections and to protect
cattle from re-infection with Cooperia oncophora and
Dictyocaulus viviparus for 21 days, and Ostertagia
ostertagi, Cooperia puctata, and oesophagostomum
radiatum for 28 days after treatment.
Date of Approval: September 16, 1997
NADA 141-095 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On solution
for cattle
Effect of Suplement: Adds to labeling a new indication
for treatment and control of horn fly, Haematobia irritans
Date of Approval: October 25 1998
NADA 141-095 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On
Effect of Suplement: Provides for addition of a therapeutic
claim for Trichostrongylus axei L4 and a persistency claim of
35 days for Haemonchus placei.
Date of Approval: August 10, 1999
NADA 141-095 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On Solution
for Cattle
Effect of Suplement: For treatment and control of gastrointestinal
roundworms, lungworms, eyeworms, grubs, lice, mange mites and
horn flies. To protect cattle from reinfection with Cooperia
oncophora, D. viviparus, Ostertagia ostertagi, and O.radiatum
for 28 days; and with C. punctata, and Haemonchus placei for
35 days after treatment.
Date of Approval: June 30, 2004
NADA 141-096 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: difloxacin hydrochloride
Trade Name: Dicural® Tablets
Indications for use: To manage diseases in dogs associated
with bacteria susceptible to difloxacin.
Date of Approval: November 20, 1997
NADA 141-097 original approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, bacitracin methylene
disalicylate
Trade Name: Ivomec® Premix for Swine +
BMD®
Indications for use: For the treatment and control
of gastrointestinal roundworms (Ascaris suum, adults
and fourth-stage larvae; Ascarops strongylina, adults;
Hyostrongylus rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourth-stage larvae),
kidneyworms (Stephanurus dentatus, adults and fourth-stage
larvae), lungworms (Metastrongylus spp., adults), threadworms
(Strongyloides ransomi, adults and somatic larvae and
prevention of transmission of infective larvae to piglets, via
the colostrum or milk, when fed during gestation), lice (Haematopinus
suis), and mange mites (Sarcoptes scabiei var. suis).
Date of Approval: February 3, 1999
NADA 141-098
Sponsor: Abbott Laboratories
Generic Name: Propofol
Trade Name: PROPOFLO
Indications for Use:
a. For induction of anesthesia.
b. For maintenance of general anesthesia for up to 20 minutes.
c. For induction of general anesthesia where maintenance is
provided by inhalant anesthetics.
Date of Approval: March 13, 1998
NADA 141-099
original approval
Sponsor: Fort Dodge Animal Health
Generic Name:moxidectin
Trade Name:CYDECTIN® (moxidectin) 0.5% Pour-On for
Cattle
Indications for use: Effective in the treatment and control
of external parasites. CYDECTIN® (moxidectin) 0.5% Pour-On
for Cattle has been proven to effectively control infections
and to protect cattle from reinfection with Ostertagia ostertagi
for 28 days following treatment and Dictyocaulus viviparus
for 42 days after treatment.
Date of Approval: January, 28, 1998
NADA 141-099 supplemental
approval
Sponsor:
Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On for
Cattle
Effect of Supplement: This supplemental application provides
for topical use of a 0.5% moxidectin solution on dairy cattle
of breeding age for treatment and control of infections and
infestations of certain internal and external parasites. In
addition, the regulations are amended to establish a tolerance
for moxidectin residues in milk.
Date of Approval: November 2, 1999
NADA 141-099 supplemental approval
Sponsor:
Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On
Effect of Supplement: This supplemental application provides
for treatment and control of infections of additional life stages
and species of gastrointestinal roundworms for topical use of
0.5% moxidectin solution on cattle.
Date of Approval: June 18, 2001
NADA 141-100 original approval
Sponsor: Alpharma, Inc.
Generic Name: Decoquinate, bacitracin methylene disalicylate,
roxarsone
Trade Name: DECCOX®,BMD®,
3-NITRO®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. nectrix, E. mivati, E. acervulina,
E. maxima, and E. brunetti, as an aid in the prevention
of necrotic enteritis caused or complicated by Clostridium
spp. or other organisms susceptible to bacitracin, and for increased
rate of weight gain, improved feed effeciency, and improved
pigmentation in broiler chickens.
Date of Approval: June 2, 1998
NADA 141-101 original approval
Sponsor: BioScience
Generic Name: competitive exclusion culture
Trade Name: PREEMPT
Indications for use: PREEMPT is indicated for the
early establishment of intestinal microflora in chickens to
reduce Salmonella colonization.
Date of Approval: March 13, 1998
NADA 141-102 original approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate Bacitracin methylene disalicylate
Trade Name: DECCOX®, BMD®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. mivati, E.
acervulina, E. maxima, and E. brunetti, and for increased
rate of weight gain and improved feed efficiency in broiler
chickens.
Date of Approval: July 24, 1998
NADA 141-103 original approval
Sponsor: Abbott Laboratories
Generic Name: Sevoflurane
Trade Name: SevoFlo™
Indications for use: For induction and maintenance of
general anesthesia.
Date of Approval: November 17, 1999
NADA 141-105 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron 10% Sterile Suspension Injectable
Trade Name: Program 6 Month Injectable for Cats
Indications for use: Program 6 Month Injectable for Cats
is indicated for use in cats, six weeks of age and older, for
the control of flea populations. Lufenuron controls flea populations
by preventing the development of flea eggs and does not kill
adult fleas. Concurrent use of insecticides may be necessary
for adequate control of adult fleas.
Date of Approval: March 31, 1998
NADA 141-107 original approval
Sponsor: Alco, Inc.
Generic Name: b -aminopropionitrile fumarate
Trade Name: BAPTEN® For Injection
Indications for use: BAPTEN is indicated for the treatment
of tendinitis of the superficial digital flexor tendon (SDFT)
in the adult horse where there is sonographic evidence of fiber
tearing.
Date of Approval: June 10, 1998
NADA 141-108 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic TM
Indications for use: Etodolac is recommended for the
management of pain and inflammation associated with osteoarthritis
in dogs.
Date of Approval: July 22, 1998
NADA 141-108 supplemental
approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic TM
Effect of Supplement:This supplement allows for the addition
of a 500 mg tablet.
Date of Approval: May 8, 2003
NADA 141-109 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: AVATEC®, BACIFERM®
Trade Name: Lasalocid plus Bacitracin Zinc
Indications for use: For the prevention of coccidiosis
caused by Eimeria meleagrimitis, E. gallopavonis,
and E. adenoeides, and for increased rate of weight gain and
improved feed efficiency in growing turkeys.
Date of Approval: April 15, 1999
NADA 141-110 original approval
Sponsor: Elanco Animal Health
Generic Name: Monesin, virginiamycin
Trade Name: Coban®, Stafac®
Indications for use: For the prevention of coccidiosis
caused by Eimeria adenoeides, E. meleagrimitis, and
E. gallopavonis, and for increased rate of weight gain and
improved feed efficiency in growing turkeys.
Date of Approval: January 29, 1999
NADA 141-111 original approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Indications for use: Rimadyl® chewable tablets are
indicated for the relief of pain and inflammation associated
with osteoarthritis in dogs.
Date of Approval: May 14, 1999
NADA 141-111 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Indications for use: Rimadyl® chewable tablets are
indicated for the relief of pain and inflamation associated
with osteoarthritis in dogs.
Effect of Supplement: This supplement provides for flexibility
in administration of the total daily dose of Rimadyl® Chewable
Tablets. The drug may be administered orally at 2 milligrams
per pound of body weight once daily or 1 milligram per pound
of body weight twice daily
Date of Approval: November 26, 2001
NADA 141-112 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin/Nicarbazin (in a 1:1 fixed dose
combination),bacitracin methylene disalicylate, roxarsone
Trade Name: Maxiban®, BMD®, 3-Nitro®
Indications for use: For prevention of coccidiosis caused
by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti,
E. mivati, and E. maxima; as an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin; for increased rate of weight
gain; improved feed efficiency, and improved pigmentation in
broiler chickens.
Date of Approval: March 4, 1999
NADA 141-113 original approval
Sponsor:Elanco Animal Health, a Division of Eli Lilly
and Co.
Generic Name: Narasin/Nicarbazin (in a 1:1 fixed dose
combination), roxarsone
Trade Name: Maxiban®, 3-Nitro®
Indications for use: For prevention of coccidiosis caused
by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti,
E. mivati, and E. maxima; for increased rate of weight gain;
improved feed efficiency, and improved pigmentation in broiler
chickens.
Date of Approval: March 4, 1999
NADA 141-114 original approval
Sponsor:Pfizer, Inc.
Generic Name: Semduramicin, virginiamycin
Trade Name: Aviax, Stafac®
Indications for use: Provides for the combined use of two
previously approved Type A Medicated Articles in the manufacture
of Type C medicated feeds.
Date of Approval: July 27, 1999
NADA 141-120
original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Clomipramine hydrochloride
Trade Name: Clomicalm Tablets
Indications for use: To be used apart of a comprehensive
behavioral management program to treat separation anxiety in
dogs greater than 6 months of age.
Date of Approval: December 10, 1998
NADA 141-121 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin,
bacitracin methylene disalicylate, roxarsone
Trade Name: BIO-COX®
/ BMD® / 3-NITRO®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E.
maxima, E. brunetti, and E. mivati, as an
aid in the prevention and control of necrotic enteritis caused
or complicated by Clostridium spp. or other organisms
susceptible to bacitracin, and for increased rate of weight
gain, improved feed efficiency, and improved pigmentation in
broiler, roaster, and replacement (breeder and layer) in chickens
not laying eggs.
Date of Approval: December 23, 1999
NADA 141-123 original approval
Sponsor: Merial Ltd.
Generic Name: Omeprazole
Trade Name: GastroGard
Indications for use: For the treatment and prevention
of recurrence of gastric ulcers in horses and foals 4 weeks
of age and older.
Date of Approval: March 16, 1999
NADA 141-124 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin,
Nicarbazin, Bacitracin methylene disalicylate
Trade Name: Maxiban
plus BMD
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati;
and as an aid in the control or prevention of necrotic enteritis
caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin.
Date of Approval: January
14, 2002
NADA 141-129 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Lasalocid,
bambermycins
Trade Name: Avatec®,
Flavomycin®
Indications for use: For
the combined use of two previously approved Type A Medicated
Articles in the manufacture of Type C medicated feeds.
Date of Approval: August
6, 1999
NADA 141-135 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin,
roxarsone
Trade Name: BIO-COX®
/ 3-NITRO®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima,
E. brunetti, and E. mivati, and for increased
rate of weight gain, improved feed efficiency, and improved
pigmentation in roaster and replacement (breeder and layer)
chickens not laying eggs.
Date of Approval: May
26, 2000
NADA 141-136 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin sodium, bacitracin methylene
disalicylate
Trade Name: Bio-Cox® plus BMD®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima,
E. brunetti, and E. mivati, as an aid in the prevention
and control of necrotic enteritis caused or complicated by Clostridium
spp. or other organisms susceptible to bacitracin, and for increased
rate of weight gain and improved feed efficiency.
Date of Approval: September
20, 2000
NADA 141-138 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin,
Bacitracin methylene disalicylate, Roxarsone
Trade Name: COBAN®, BMD®, 3-NITRO®
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima,
E. brunetti, and E. mivati, as an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin, and for increased rate
of weight gain, improved feed efficiency, and improved pigmentation
in replacement chickens intended for use as cage layers; As
an aid in the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati,
as an aid in the control of necrotic enteritis caused or complicated
by Clostridium spp. or other organisms susceptible to bacitracin,
and for increased rate of weight gain, improved feed efficiency,
and improved pigmentation in replacement chickens intended for
use as cage layers.
Date of Approval: June
28 2000
NADA 141-139 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Roxarson
Trade Name: COBAN®, 3-NITRO
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima,
E. brunetti, and E. mivati, and for increased rate of weight
gain, improved feed efficiency, and improved pigmentation in
replacement chickens intended for use as cage layers.
Date of Approval: June 28 2000
NADA 141-140 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and for
increased rate of weight gain and for improved feed efficiency
in replacement chickens intended for use as cage layers; As
an aid in the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and as
an aid in the prevention of necrotic enteritis caused or complicated
by Clostridium spp. or other organisms susceptible to bacitracin
in broiler chickens and replacement chickens intended for use
as cage layers.
Date
of Approval: January 2, 2001
NADA 141-142 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate,
Roxarsone
Trade Name: AMPROL®, BMD®, 3-NITRO®
Indications for use: For development of active immunity
to coccidiosis, as an aid in the prevention of necrotic enteritis
caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin, and for increased rate of weight
gain, improved feed efficiency, and improved pigmentation in
replacement chickens.
Date
of Approval: February 16, 2001
NADA 141-143 original approval
Sponsor: Norbrook Laboratories Limited
Generic Name: Oxytetracycline injection
Trade Name: TETRADURE 300 (Oxytetracycline) Injection
(Rx product),
OXYTETRACYCLINE INJECTION 300 mg/mL (OTC product)
Indications for use: Beef and non-lactating dairy cattle,
calves, including pre-ruminating (veal) calves: for the treatment
of pneumonia and shipping fever complex associated with Pasteurella
spp. and Haemophilus spp.; infectious bovine keratoconjunctivitis
(pinkeye) caused by Moraxella bovis; foot-rot and diphtheria
caused by Fusobacterium necrophorum; bacterial enteritis (scours)
caused by Escherichia coli; wooden tongue caused by Actinobacillus
lignieresi; leptospirosis caused by Leptospira pomona; and wound
infections and acute metritis caused by strains of staphylococcal
and streptococcal organisms sensitive to oxytetracycline. Also,
TETRADURE 300 is indicated (prescription use) for the control
of respiratory disease in cattle at high risk of developing
BRD associated with Mannheimia (Pasteurella) haemolytica. Swine:
for the treatment of bacterial enteritis (scours, colibacillosis)
caused by Escherichia coli; pneumonia caused by Pasteurella
multocida; and leptospirosis caused by Leptospira pomona. In
sows, oxytetracycline is indicated as an aid in the control
of infectious enteritis (baby pig scours, colibacillosis) in
suckling pigs caused by Escherichia
Date of Approval: July 25, 2003
NADA 141-144 original approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin
methylene disalicylate, fenbendazole
Trade Name: BMD® / SAFE-GUARD®
Indications for use: Indications: Fenbendazole
is indicated for the removal of
Lungworms: adult (Metastrongylus apri, M. pudendotectus)
Roundwords:
adult and larvae (L3, L4 stages - liver, lung, and intestinal
forms) Large
roundworms adult, larvae (L3, L4 stages-liver, lung, and
intestinal forms) (Ascaris suum) Nodular
worms adult (Oesophagostomum dentatum, O. quadrispinulatum)
Small
stomach worms (Hyostrongylus rubidus) Whipworms
adult and larvae (L2, L3, L4 stages - intestinal mucosal forms)
(Trichuris suis). Kidney
worms: adult and larvae (Stephanurus dentatus). Bacitracin
methylene disalicylate is indicated for: Increased
rate of weight gain and improved feed efficiency in growing
and finishing swine. Control
of clostridial enteritis in suckling pigs caused by Clostridium
perfringens when fed to pregnant sows during the period
from 14 days before farrowing through 21 days after farrowing.
Control
of swine dysentery associated with Treponema hyodysenteriae
in growing and finishing swine on premises with a history of
swine dysentery but where signs of disease have not yet occurred
or following an approved treatment of the disease.
Date of Approval: April 7, 2000
NADA 141-146 original approval
Sponsor: Koffolk, Inc. 14735 Las Quintas
Generic Name: Nicarbazin, Bacitracin zinc
Trade Name: NICARB® BACIFERM®
Indications for use: As an aid in preventing outbreaks
of cecal (Eimeria tenella) and intestinal (E. acervulina, E.
maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased
rate of weight gain and improved feed efficiency in broiler
chickens.
Date of Approval: February 2, 2000
NADA 141-147 original approval
Sponsor: Alpharma, Inc
Generic Name: Decoquinate, chlortetracycline
Trade Name: Deccox® plus Chloromax®
Indications for use: For the prevention of coccidiosis
caused by Eimeria bovis and E. zuernii; for the treatment of
bacterial enteritis caused by Escherichia coli and bacterial
pneumonia caused by Pasteurella multocida organisms susceptible
to chlortetracycline.
Date of Approval: September 29, 2000
NADA 141-148 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin
Trade Name: DECCOX® RUMENSIN®
Indications for use: For the prevention of coccidiosis
caused by Eimeria bovis and E. zuernii, and for
increased feed efficiency in cattle being fed in confinement
for slaughter.
Date of Approval: November 16, 2000
NADA 141-148 supplemental
approval
Sponsor: Alpharma, Inc
Generic Name: Decoquinate, monensin sodium
Trade Name: DECCOX® / RUMENSIN®
Indications for use: For the prevention of coccidiosis
caused by Eimeria bovis and E. zuernii; and improved feed efficiency
in cattle being fed in confinement for slaughter.
Date of Approval: July 30, 2004
NADA 141-149 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin, tylosin
Trade Name: Deccox® Rumensin® Tylan®
Indications for use: For the prevention of coccidiosis
caused by Eimeria bovis, and E. zuernii, for improved
feed efficiency and for reduction of incidence of liver abscesses
caused by Fusobacterium necrophorum and Actinomyces
pyogenes in growing-finishing cattle being fed in confinement
for slaughter.
Date of Approval: November 16, 2000
NADA 141-150 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Lasalocid,
virginiamycin
Trade Name: Avatec®,
Stafac®
Indications for use: For
the combined use of two previously approved Type A Medicated
Articles in the manufacture of Type C medicated feeds.
Date of Approval: August
6, 1999
NADA 141-151 original approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin
Indications for use:
Zeniquin (marbofloxacin) tablets are indicated for the
treatment of infections in dogs associated with bacteria susceptible
to marbofloxacin.
Clinical effectiveness was confirmed in skin and soft tissue
infections and urinary tract infections (cystitis) associated
with bacteria susceptible to marbofloxacin.
Date of Approval: June 26, 1999
NADA 141-151 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin
Effect of supplement: Provides for the use of Zeniquin
(marbofloxacin) tablets in cats as indicated below.
Date of Approval: August 1, 2001
NADA 141-152 original approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution
Indications for use: kills adult fleas and prevents
flea eggs from hatching for one month and is indicated for the
prevention and control of flea infestations (Ctenocephalides
felis), prevention of heartworm disease caused by Dirofilaria
immitis, and the treatment and control of ear mite (Otodectes
cynotis) infestations in dogs and cats.
Date of Approval: May 26, 1999
NADA 141-152 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution
Effect of Supplement: Provides for the additional indication
for control of tick infestations in dogs
Date of Approval: August 5, 1999
NADA 141-152 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution
Effect of Supplement: Provides for the addition of a
claim for the prevention and control of coccidiosis caused by
Eimeria bovis and E. zuernii.
Date of Approval: June 13, 2000
NADA 141-153 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate,
Trade Name: Clinacox , BMD®
Indications for use: For
the prevention of coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. brunetti, E. mitis (mivati) and E.
maxima. Because diclazuril is effective against E. maxima later
in its life cycle, subclinical intestinal lesions may be present
for a short time after infection. Diclazuril was shown in studies
to reduce lesion scores and improve performance and health of
birds challenged with E. maxima. For increased rate of weight
gain and improved feed efficiency in broiler chickens.
Date of Approval: January 13, 2000
NADA 141-154 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene
disalicylate
Trade Name: Robenz® plus BMD®
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E acervulina, E.
maxima, E. brunetti, and E. mivati and as an aid in the
control or prevention of necrotic enteritis caused or complicated
by Clostridium spp. or other organisms susceptible to bacitracin.
Date of Approval: February 11, 2002
NADA 141-155 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene
disalicylate, Roxarsone
Trade Name: Robenz®, BMD®, 3-Nitro®
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E acervulina, E.
maxima, E. brunetti, and E. mivati and as an aid in the
prevention and controlof necrotic enteritis caused or complicated
by Clostridium spp. or other organisms susceptible to bacitracin,
and for increased rate of weight gain, improved feed efficiency,
and improved pigmentation in broiler chickens; .
Date of Approval: July 3, 2000
NADA 141-156 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate
Trade Name: AMPROL®, BMD®
Indications for use: For the development of active immunity
to coccidiosis, and for increased rate of weight gain and improved
feed efficiency in replacement chickens.
Date of Approval: February 12, 2001
NADA 141-157 original approval
Sponsor: Alpharma, Inc.
Generic Name: Halofuginone
hydrobromide, roxarsone
Trade Name: Stenorol®
/ 3-Nitro®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima,
E. brunetti, and E. mivati (E. mitis),
and for increased rate of weight gain, improved feed efficiency,
and improved pigmentation in chickens not laying eggs.
Date of Approval: July
3, 2000
NADA 141-158 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril; Bambermycins
Trade Name: Clinacox
; Flavomycin®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima,
E. brunetti, and E. mivati (E. mitis).
Because diclazuril is effective against E. maxima later in its
life cycle, subclinical intestinal lesions may be present for
a short time after infection. Diclazuril was shown in studies
to reduce lesion scores and improve performance and health of
birds challenged with E. maxima. For increased rate weight gain
and improved feed efficiency in broiler chickens.
Date of Approval: July
3, 2000
NADA 141-162 original approval
Sponsor: Wellmark International
Generic Name: (S)-Methoprene
Trade Name: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® FLEA
CONTROL CAPSULES™
Indications for use: ZODIAC® FLEATROL™ FLEA CAPS™ and
HARTZ® Flea Control Capsules™ are indicated for use in dogs,
nine weeks of age and older and 4 pounds body weight or greater,
for the prevention and control of flea populations. (S)-Methoprene
prevents and controls flea populations by preventing the development
of flea eggs and does not kill adult fleas. Concurrent use of
insecticides may be necessary for adequate control of adult
fleas.
Date of Approval: January 24, 2000
NADA 141-163 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Indications for use: MILBEMITE OTIC Solution is indicated
for treatment of ear mite (Otodectes cyanotis) infestations
in cats and kittens eight weeks of age and older. Effectiveness
is maintained throughout the life cycle of the ear mite.
Date of Approval: February 2, 2000
NADA 141-163 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Effect of Supplement: This supplement provides target
animal safety study data to lower the age limitation of the
product from 8 to 4 week old kittens and to allow a repeat treatment
if necessary.
Date of Approval: December 13, 2000
NADA 141-164 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Tylosin phosphate
Trade Name: COBAN®, TYLAN®
Indications for use: As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima,
E. brunetti, and E. mivati, and for increased rate of weight
gain and improved feed efficiency in broiler chickens.
Date of Approval: July
3, 2000
NADA 141-170 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
& Co.
Generic Name: Narasin, tylosin phosphate
Trade Name: Monteban® plus Tylan®
Indications for use: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti,
E. mivati, and E. maxima, for increased rate of weight gain
and improved feed efficiency.
Date of Approval: September 20, 2000
NADA 141-171 original approval
Sponsor: Purina Mills, Inc.
Generic Name: Lasalocid
Trade Name: Purina Sugar Mag Block 1440 BVT Medicated
Mineral Block
Indications for use: For increased rate of weight gain.
Date of Approval: August 20, 2002
NADA 141-172 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
& Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Indications for use: 1) For increased weight gain, improved
feed efficiency and increased carcass leanness in finishing
swine fed a complete ration containing at least 16% crude protein
from 150 lb (68kg) to 240 lb (109 kg) body weight, and for prevention
and/or control of porcine proliferative enteropathies (ileitis)
associated with Lawsonia intracellularis. 2)
For improved feed efficiency and increased carcass leanness
in finishing swine fed a complete ration containing at least
16% crude protein from 150 lb (68kg) to 240 lb (109 kg) body
weight, and for prevention and/or control of porcine proliferative
enteropathies (ileitis) associated with Lawsonia intracellularis.
Date of Approval: February 20, 2001
NADA 141-172 supplemental
approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
& Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Indications for use: This supplemental application provides
for use of ractopamine and tylosin single-ingredient Type A
Medicated Articles.
Date of Approval: June 19, 2002
NADA 141-174 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin otic suspension
Trade Name: ACAREXX™
Indications for use: ACAREXX is indicated for the treatment
of adult ear mite (Otodectes cynotis) infestations in cats and
kittens four weeks of age or older. Effectiveness against eggs
and immature stages has not been proven.
Date of Approval: December
5 , 2000
NADA 141-175 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Indications for use: For the treatment of flea infestations
Date of Approval: October
20, 2000
NADA 141-175 supplemental
approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Date of Approval: June
11, 2003
NADA 141-176 original approval
Sponsor: BAYER Corporation
Generic Name: Enrofloxacin/Silver Sulfadiazine
Trade Name: Baytril® Otic
Indications for use: Baytril® Otic is indicated for the
treatment of canine otitis externa complicated by acterial and
fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
Date of Approval: September 29, 2000
NADA 141-177 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, Clotrimazole, Mometasone
furoate monohydrate
Trade Name: Mometamax™ Otic Suspension
Indications for use: Mometamax™ Otic Suspension is indicated
for the treatment of otitis externa associated with yeast (Malassezia
pachydermatis) and/or bacteria susceptible to gentamicin in
dogs.
Date of Approval: December
5 , 2000
NADA 141-177 supplemental
approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Gentamicin, mometasone, and clotrimazole
Trade Name: Mometamax™
Indications for use: For the treament of otitis externa
caused by susceptible strains of yeast (Malassezia pachydermatis)
and certain bacteria (Pseudomonas supp. including P. aeruginosa,
coagulase positive staphylococci, Enterococcus faecalis, Proteus
mirabilis and beta-hemolytic streptococci).
Date of Approval: January
9, 2003
NADA 141-178 original approval
Sponsor: IDEXX Pharmaceuticals, Inc.
Generic Name: Nitazoxanide
Trade Name: NAVIGATOR (32% nitazoxanide) Antiprotozoal
Oral Paste
Indications for use: NAVIGATOR (32% nitazoxanide) Antiprotozoal
Oral Paste in indicated for the treatment of horses with equine
protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
Date of Approval: November 18, 2003
NADA 141-178 original approval
Sponsor: Ridley Block Operations Inc.
Generic Name: Lasalocid
Trade Name: BOVATEC 68 CRYSTALYX IONO-LYX
Indications for use: For increased rate of weight gain
in pasture cattle (slaughter, stocker, feeder cattle, and dairy
and beef replacement heifers).
Date of Approval: December 12, 2003
NADA 141-178 supplemental approval
Sponsor: RIDEXX Pharmaceuticals, Inc
Generic Name: Lanitazoxani
Trade Name: BNAVIGATOR (32% nitazoxanide) Antiprotozoal
Oral Past
Indications for use: FNAVIGATOR (32% nitazoxanide) Antiprotozoal
Oral Paste in indicated for the treatment of horses with equine
protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: November 18, 2003
NADA 141-179 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, Bacitracin methylene
disalicylate
Trade Name: AVATEC®, BMD®
Indications for use: For the prevention of coccidiosis
caused by Eimeria meleagrimitis, E. gallopavonis, and
E. adenoeides, and for increased rate of weight gain and improved
feed efficiency in growing turkeys.
Date of Approval: July 11, 2001
NADA 141-180 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Albuterol sulfate
Trade Name: Torpex
Indications for use: For the immediate relief of bronchospasm
and bronchoconstriction associated with reversible airway obstruction
in horses.
Date of Approval: November 16, 2001
NADA 141-181 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Bacitracin zinc
Trade Name: AVATEC, ALBAC
Indications for use: For the prevention of coccidiosis
caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides,
and for increased rate of weight gain and improved feed efficiency
in growing turkeys.
Date of Approval: May 15, 2002
NADA 141-185 original
approval
Sponsor: Alpharma, Inc.
Generic Name:decoquinate, chlortetracycline
Trade Name: Deccox® plus Aureomycin®
Indications for use: For the prevention of coccidiosis
caused by Eimeria bovis and E. zuernii; for the treatment of
bacterial enteritis caused by Escherichia coli, and for bacterial
pneumonia caused by Pasteurella multocida organisms susceptible
to chlortetracycline.
Date of Approval: March 15, 2002
NADA 141-186 original
approval
Sponsor: IDEXX Pharmaceuticals, Inc..
Generic Name: 1% diclofenac sodium
Trade Name: SURPASS™
Indications for use: For the control of pain and inflammation
associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal,
metatarsophalangeal, and proximal interphalangeal (hock, knee,
fetlock, and pastern) joints.
Date of Approval: May 13, 2004
NADA 141-187 supplemental
approval
Sponsor: Ridley Block Operations Inc.
Generic Name: Lasalocid
Trade Name: DBOVATEC 68
CRYSTALYX IONO-LY
Indications for use: For increased rate of weight gain
in pasture cattle (slaughter, stocker, feeder cattle, and dairy
and beef replacement heifers).
Date of Approval: December 12, 2003
NADA 141-188 original approval
Sponsor: Bayer Animal Health
Generic Name: Ponazuril
Trade Name: Marquis
Indications for use: For the treatment of Equine Protozoal
Myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: July 19, 2001
NADA 141-189 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable
for Dogs
Indications for use: For the prevention of heartworm
disease caused by Dirofilaria immitis and for treatment of existing
larval and adult hookworm (Ancylostoma caninum) infections.
Date of Approval: June 06, 2001
NADA 141-189 supplemental
approval
Sponsor: Fort Dodge Animal Health, Div. of American Home
Products, Inc.
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable
for Dogs
Indications for use: New indication for the treatment
of existing larval and adult hookworm (Uncinaria stenocephala)
infections.
Date of Approval: June 13, 2002
NADA 141-190 original
approval
Sponsor: Schering-Plough Animal Health
Generic Name:Diclazuril, Bacitracin methylene disalicylate,
Roxarsone
Trade Name: Clinacox plus BMD® plus 3-Nitro®
Indications for use: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E.
brunetti, E. mitis (mivati), and E. maxima. Because diclazuril
is effective against E. maxima later in its life cycle,
subclinical intestinal lesions may be present for a short time
after infection. Diclazuril was shown in studies to reduce lesion
scores and improve performance and health of birds challenged
with E. maxima. As an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin or as an aid in the control
of necrotic enteritis caused or complicated by Clostridium spp.
or other organisms susceptible to bacitracin. For increased
rate of weight gain, improved feed efficiency and improved pigmentation
in broiler chickens.
Date of Approval: December 14, 2001
NADA 141-192 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: Ralgro® L.A.
Indications for use: For increased rate of weight gain
for up to 210 days.
Date of Approval: November 1, 2001
NADA
141-193 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: tepoxalin
Trade Name: ZUBRIN Rapidly-Disintegrating Tablets
Indications for use: ZUBRIN™ (tepoxalin) Tablets are
indicated for the control of pain and inflammation associated
with osteoarthritis in dogs.
Date of Approval: March 31, 2003
NADA 141-194 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate
Trade Name: CLINACOX, BMD®
Indications for use: Growing Turkeys: For the prevention
of coccidiosis caused by Eimeria adenoeides, E. gallopavonis,
and E. meleagrimitis, and for increased rate of weight gain
and improved feed efficiency in growing turkeys.
Date of Approval: April 2, 2002
NADA 141-195 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bambermycins
Trade Name: CLINACOX, FLAVOMYCIN®
Indications for use: Growing Turkeys: For the prevention
of coccidiosis caused by Eimeria adenoeides, E. gallopavonis,
and E. meleagrimitis, and for improved feed efficiency in growing
turkeys or for the prevention of coccidiosis caused by Eimeria
adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased
rate of weight gain and improved feed efficiency in growing
turkeys.
Date of Approval: April 2, 2002
NADA 141-198 original approval
Sponsor: Elanco Animal Health, A division of Eli Lilly
and Co.
Generic Name: Tylosin, salinomycin
Trade Name: Tylan® /Bio-Cox®
Indications for use: For increased rate of weight gain
and improved feed efficiency, and as an aid in the prevention
of coccidiosis caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunette, and E. mivati.
Date of Approval: September 4, 2002
NADA 141-199 original approval
Sponsor: Pfizer, Inc.
Generic Name: Acarprofen
Trade Name: RIMADYL® INJECTABLE
Indications for use: Rimadyl® Injectable is indicated
for the relief of
pain and inflammation associated with
osteoarthritis in dogs.
Date of Approval: March 3, 2003
NADA 141-199 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: Acarprofen
Trade Name: RIMADYL® INJECTABLE
Indications for use: Rimadyl® Injectable is indicated
for the relief of
pain and inflammation associated with
osteoarthritis in dogs.
Date of Approval: March 25, 2003
NADA 141-199 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Effect of Supplement: This supplement to NADA 141-199
provides
revisions to 21CFR 522.312 (2) Indications for Use.
To add a claim for the control of postoperative pain
associated with soft tissue and orthopedic surgeries
in dogs.
Date of Approval: April 2, 2003
NADA 141-200
original approval
Sponsor: DEC INTERNATIONAL, INC
Generic Name: Intravaginal Progesterone Insert
Trade Name: EAZI-Breed CIDR® Cattle Insert
Indications for use: 1. Synchronization of estrus in
suckled beef cows, and replacement beef and dairy heifers. 2.
Advancement of first postpartum estrus in suckled beef cows.
3. Advancement of first pubertal estrus in replacement beef
heifers.
Date of Approval: May
2, 2002
NADA 141-200 original approval
Sponsor: DEC INTERNATIONAL, INC
Generic Name: Intravaginal Progesterone Insert
Trade Name: EAZI-Breed CIDR® Cattle Insert
Indications for use: 1. Synchronization of estrus in
suckled beef cows, and replacement beef and dairy heifers. 2.
Advancement of first postpartum estrus in suckled beef cows.
3. Advancement of first pubertal estrus in replacement beef
heifers.
Date of Approval: May
2, 2002
NADA 141-200 supplemental
approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: Progesterone
Trade Name: EAZI-Breed CIDR® Cattle Insert
Indications for use: For synchronization of the return
to estrus in lactating dairy cows inseminated at the immediately
preceding estrus
Date of Approval: The
supplement provides for the synchronization of the return to
estrus in lactating dairy cows inseminated at the immediately
preceding estrus.
NADA 141-203 original approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Indications for use: DERAMAXX™ Chewable Tablets are indicated
for the
control of postoperative pain and inflammation associated with
orthopedic surgery in dogs > 4 lbs (1.8 kg).
Date of Approval: August
21, 2002
NADA 141-203 supplemental
approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Effect of Supplement: The supplement to NADA 141-203
provides revisions to 21 CFR 520.538. Indications for Use. To
add a claim for the control of pain and inflammation associated
with osteoarthritis in dogs.
Amount: To add a new dose range of 1-2 mg/kg (0.45-0.91 mg/lb).
Date of Approval: February
11, 2003
NADA 141-204 original approval
Sponsor: Novartis Animal Health US
Generic Name: Milbemycin oxime/lufenuron, nitenpyram
Trade Name: Sentinel® Flavor Tabs® , Capstar®
Tablets, Flea Management System™
Indications for use: For use in dogs 4 weeks and older
to kill adult fleas and to prevent flea eggs from hatching.
Date of Approval: June 11, 2003
NADA 141-205 original approval
Sponsor: Novartis Animal Health US
Generic Name: Lufenuron, nitenpyram
Trade Name: Sentinel® Flavor Tabs® , Capstar®
Tablets, Flea Management System™
Indications for use: For use to kill adult fleas and
to prevent flea eggs from hatching.
Date of Approval: June 11, 2003
NADA 141-206 original approval
Sponsor: Schering-Plough Animal Health
Generic Name:Florfenicol
Trade Name: Nuflor® 2.3% Concentrate Solution
Indications for use: For treatment of swine respiratory
disease associated with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Salmonella choleraesuis, and Streptococcus
suis Type 2.
Date of Approval: September 4, 2002
NADA 141-207
original approval
Sponsor: Pfizer, Inc.
Generic Name: Danofloxacin mesylate
Trade Name: A 180®
Indications for use: For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia (Pastreurella) haemolytica
and Pasteurella multocida.
Date of Approval: September
20, 2002
NADA 141-208 original approval
Sponsor: Bayer Corp.
Generic Name: Imidacloprid, invermectin
Trade Name: Advantage® DUO
Indications for use: For the prevention of heartworm
disease caused by Dirofilaria immitis. Also indicated for the
treatment of flea infestation (Ctenocephalides felis).
Date of Approval: September
27, 2002
NADA 141-209 original approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: ceftiofur crystalline free acid
Trade Name: NAXCEL XT STERILE SUSPENSION
Indications for use: NAXCEL XT STERILE SUSPENSION is
indicated for treatment of BRD, shipping fever, pneumonia) associated
with Mannheimia haemolytica, P. multocida and H. omnus. NAXCEL
XT STERILE SUSPENSION is also indicated for the control of respiratory
disease in cattle which are at high risk of developing BRD associated
with Mannheimia. haemolytica, P. multocida and H. somnus.
Date of Approval: September 5, 2003
NADA 141-210 original approval
Sponsor: RMS Laboratories, Inc.
Generic Name: Triamcinolone acetonide
Trade Name: Genesis Topical Spray
Indications for use: For the control of pruritus associated
with allegic dematitis.
Date of Approval: November
4 , 2002
NADA 141-211 original approval
Sponsor: Phibro Animal Health
Generic Name: Carbadox, oxytetracycline dihydrate base
Trade Name: Mecadox® 10 / Terramycin® 50, 100, or 200
Indications for use: For the treatment of bacterial enteritis
caused by Escherichia coli and Salmonella choleraesuis susceptible
to oxytetracycline, treatment of bacterial pneumonia caused
by Pasteurella multocida susceptible to oxytetracycline, and
increased rate of weight gain and improved feed efficiency.
Date of Approval: July 21, 2004
NADA 141-213 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: meloxicam
Trade Name: Metacam® Oral Suspension
Indications for use: Metacam® Oral Suspension is
indicated for the control of pain and inflammation associated
with osteoarthritis in
Date of Approval: April
15, 2003
NADA 141-214 original approval
Sponsor: Merial Limited
Generic Name: Ivermectin/praziquantel
Trade Name: Zimecterin® Gold Paste
Indications for use: For treatment and control of the
following parasites in horses: Tapeworms: noplocephala perfoliata
Large strongyles (adults):
Strongylus vulgaris (also early forms in blood vessels) Strongylus
edentatus (also tissue stages) Strongylus equinus Triodontophorus
spp. including: Triodontophorus brevicauda Triodontophorus serratus
Craterostomum acuticaudatum Small strongyles: Including those
resistant to some benzimidazole class compounds (adults and
4th stage larvae)
Coronocyclus spp. including: Coronocyclus coronatus Coronocyclus
labiatus Coronocyclus labratus Cyathostomum spp. including:
Cyathostomum catinatum Cyathostomum pateratum Cylicocyclus spp.
including: Cylicocyclus insigne Cylicocyclus leptostomum Cylicocyclus
nassatus Cylicocyclus brevicapsulatus Cylicodontophorus spp.
Cylicostephanus spp. including: Cylicostephanus calicatus Cylicostephanus
goldi Cylicostephanus longibursatus Cylicostephanus minutus
Petrovinema poculatum Pinworms (adults and 4th stage larvae)
- Oxyuris equi Ascarids (adults and 3rd and 4th stage larvae)
- Parascaris equorum Hairworms (adults) - Trichostrongylus axei
Large-mouth stomach worms (adults) - Habronema muscae Bots (oral
and gastric stages) – Gasterophilus spp. including G. intestinalis
and G. nasalis
Lungworms (adults and 4th stage larvae) - Dictyocaulus arnfieldi
Intestinal threadworms (adults) - Strongyloides westeri Summer
sores caused by Habronema and Draschia spp. cutaneous third-stage
larvae; dermatitis caused by neck threadworm microfilariae,
Onchocerca
Date of Approval: April
17, 2003
NADA 141-214 supplemental
approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, praziquantel
Trade Name: Zimermectin® Gold Paste
Date of Approval: July 13, 2004
NADA 141-215 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/Pra
ziquantel Paste
Trade Name: EQUIMAXTM
Paste
Indications for use: Indications:
Consult your veterinarian for assistance in the diagnosis, treatment
and control of parasitism. EQUIMAX (ivermectin/praziquantel)
Paste is indicated for the treatment and control of the following
parasites:
Tapeworms: Anoplocephala perfoliata
Large Strongyles (adults): Strongylus vulgaris (also early forms
in blood vessels), S. edentatus (also tissue stages), S. equinus,
Triodontophorus spp.
Small Strongyles including those resistant to some benzimidazole
class compounds (adults and fourth-stage larvae): Cyathostomum
spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus
spp.
Pinworms (adults and fourth-stage larvae): Oxyuris equi
Ascarids (adults and third- and fourth-stage larvae): Parascaris
equorum
Hairworms (adults): Trichostrongylus axei
Large-mouth Stomach Worms (adults): Habronema muscae
Bots (oral and gastric stages): Gasterophilus spp.
Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi
Intestinal Threadworms (adults): Strongyloides westeri
Summer sores caused by Habronema and Draschia spp. cutaneous
third- stage larvae.
Dermatitis caused by Neck threadworm microfilariae, Onchocerca
Date of Approval: July
11, 2003
NADA
141-215 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/praziquantel
Trade Name: EQUIMAX
Effect of Supplement: This supplement provides for the
use of EQUIMAX Paste in breeding, pregnant or lactating mares
without adverse effects on fertility.
Date of Approval: July 30, 2004
NADA
141-216 original approval
Sponsor: Fort Dodge Animal Health, Division
of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for use: For the treatment and control of
the following stages of gastrointestinal parasites of horses
and ponies six months of age and older and not to be used for
food
Date of Approval: May 14, 2003
NADA
141-216 original approval
Sponsor: Fort Dodge Animal Health, Division
of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for use: For the treatment and control
of the following stages of gastrointestinal parasites of horses
and ponies
Date of Approval: March 17, 2004
NADA
141-217 original approval
Sponsor: Technology Transfer, Inc.
Generic Name: Zinc Gluconate Neutralized by
Arginine
Trade Name: Neutersol® Injectable Solution
Indications for use: Neutersol® Injectable Solution
is indicated for chemical sterilization in 3 to 10 month old
male dogs.
Date of Approval: March 17, 2003
NADA 141-218 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Cyclosporine
capsules, USP Modified
Trade Name: ATOPICA
Indications for use: For
the control of atopic dermatitis in dogs weighing at least 4
lbs body weight.
Date of Approval: August
15, 2003
NADA 141-219 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Meloxicam
Trade Name: AMETACAM
(meloxicam) 5 mg/mL Solution for Injectio
Indications for use: METACAM
(meloxicam) 5 mg/mL Solution for Injection is indicated for
the control of pain and inflammation associated with osteoarthritis
in dogs.
Date of Approval: November
12, 2003
NADA 141-221 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
& Co.
Generic Name: Ractopamine
hydrochloride
Trade Name: OPTAFLEXX
45
Indications for use: 1)
(8.2 24.6 g/ton) - For increased rate of weight gain,
and improved feed efficiency in cattle fed in confinement for
slaughter during the last 28 to 42 days on feed.
2) ( 9.8 24.6 g/ton) - For increased rate of weight gain,
improved feed efficiency, and increased carcass leanness in
cattle fed in confinement for slaughter during the last 28 to
42 days on feed.
Date of Approval: J
NADA 141-222 original approval
Sponsor: Intervet, Inc.
Generic Name: Altrenogest
Trade Name: MATRIX
Indications for use: For
synchronization of estrus in sexually mature gilts that have
had at least one estrous cycle.
Date of Approval: September
30, 2003
NADA 141-223 original approval
Sponsor:Alpharma, Inc..
Generic Name:
Diclazuril, roxarsone
Trade Name: Clinacox
™ / 3-Nitro®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. brunette, E. mitis (mivati),
and E. maxima. Also, for increased rate of weight
gain, improved feed efficiency, and improved pigmentation.
Date of Approval:
January 27, 2004
NADA 141-224 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly
& Co.
Generic Name: Ractopamine
hydrochloride, monensin sodium, tylosin phosphate
Trade Name:Optaflexx ™ / Rumensin ® / Tylan
®
Indications for use:
Increased rate of weight gain, improved feed efficiency, increased
carcass leanness, prevention and control of coccidiosis due
to Eimeria bovis and E. zuernii, and reduction
of incidence of liver abscesses caused by Fusobacterium
necrophorum and Actinomyces (Corynebacterium) pyogenes
in cattle fed in confinement for slaughter for the last 28 to
42 days on feed.
Date of Approval:
January 27, 2004
NADA 141-225 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly
& Co.
Generic Name: Ractopamine
hydrochloride, monensin sodium
Trade Name: Optaflexx
™ / Rumensin ®
Indications for use:
Increased rate of weight gain, improved feed efficiency, increased
carcass leanness, and prevention and control of coccidiosis
due to Eimeria bovis and E. zuernii in cattle
fed in confinement for slaughter for the last 28 to 42 days
on feed.
Date of Approval:
January 27, 2004
NADA 141-226 original approval
Sponsor: Phibro Animal Health
Generic Name:
Semduramicin, virginiamycin, roxarsone
Trade Name: Aviax
™ / Stafac ® / 3-Nitro ®
Indications for use: For
the prevention of coccidiosis caused by Eimeria tenella,
E. acervulina, E. maxima, E. brunetti, E. necatrix, and
E. miva (E. mitis), for the prevention of necrotic
enteritis caused by Clostridium perfringens susceptible
to virginiamycin, for increased rate of weight gain and improved
feed efficiency, and improved pigmentation.
Date of Approval:
February 23, 2004
NADA 141-227 original approval
Sponsor: Merial Ltd.
Generic Name:
Omeprazole
Trade Name:UlcerGard ™
Indications for use: For the prevention of gastric ulcers.
.
Date of Approval:
February 18, 2004
NADA 141-228 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name:
N-butylscopolammonium bromide
Trade Name:Buscopan™ Injectable Solution
Indications for use: BUSCOPAN Injectable Solution is
indicated for the control of abdominal pain (colic) associated
with spasmodic colic, flatulent colic, and simple impactions
in horses.
Date of Approval:
May 03, 2004
NADA 141-229 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Romifidine hydrochloride
Trade Name: Sedivet® 1% Injection
Indications for use: For use as a sedative and analgesic
to facilitate handling, clinical examinations, clinical procedure,
and minor surgical procedures. Also used as a preanesthetic
prior to the induction of general anesthesia.
Date of Approval:
June 3, 2004
NADA 141-230 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: Previcox™
Indications for use: For the control of pain and inflammation
associated with osteoarthritis in dogs.
Date of Approval:
July 21, 2004
NADA 141-232 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Cefpodoxime proxetil
Trade Name: Simplicef™
Indications for use: For the treatment of skin infections
(wounds and abscesses) caused by susceptible strains of Staphylococcus
intermedius, Staphylococcus aureus, Streptococcus canis (group
G, β hemolytic), Escherichia coli, Pasteurella multocida,
and Proteus mirabilis.
Date of Approval:
July 22, 2004
NADA 141-233 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly
& Co.
Generic Name: Ractopamine hydrochloride, monensin sodium,
tylosin phosphate, melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / Tylan® / MGA®
Indications for use: For increased rate of weight gain,
improved feed efficiency, increased carcass leanness, prevention
and control of coccidiosis due to Eimeria bovis and E. zuernii,
reduction of incidence of liver abscesses caused by Fusobacterium
necrophorum and Actinomyces (Corynebacterium) pyogenes, and
suppression of estrus (heat) in heifers fed in confinement for
slaughter for the last 28 to 42 days on feed.
Date of Approval:
July 2, 2004
NADA 141-234 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly
& Co.
Generic Name: Ractopamine hydrochloride, monensin sodium,
melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / MGA®
Indications for use: For increased rate of weight gain,
improved feed efficiency, increased carcass leanness, prevention
and control of coccidiosis due to Eimeria bovis and E. zuernii,
and suppression of estrus (heat) in heifers fed in confinement
for slaughter for the last 28 to 42 days on feed.
Date of Approval:
July 2, 2004
NADA 141-235 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name:
Ceftiofur crystalline free acid
Trade Name: Excede™ For Swine
Indications for use: For the treatment of swine respiratory
disease (SRD) associated with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Haemophilus parasuis, and Streptococcus
suis.
Date of Approval: June 18, 2004
NADA 141-236 original approval
Sponsor: Intervet, Inc.
Generic Name:
Porcine insulin zinc
Trade Name: Vetsulin™
Indications for use: For the reduction of hyperglycemia
and hyperglycemia associated clinical signs with diabetes mellitus.
Date of Approval:
April 1, 2004
Web page updated by swd,
October 20, 2004, 10:22 AM ET
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