FOI Documents NADA 000-000 to 139-999
Listed with Abstracts from the Summaries
NADA 006-707 supplemental
approval
Sponsor: Solvay Animal Health, Inc.
Generic Name: Oxytetracycline (from oxytetracycline quaternary
salt) equivalent to oxytetracycline hydrochloride
Trade Name: Sulquin 6-50 Concentrate
Effect of Supplement: DESI finalization recognizing that
Sulquin 6-50 Concentrate is, when used as directed, safe and
effective for the labeled indications.
Date of Approval: June 2, 1997
NADA 008-622 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline Soluble Powder
Trade Name: Terramycin Soluble Powder
Effect of Supplement: One supplemental application is
a Category II change to bring the drug product into compliance
with the National Academy of Science/National Research Council
Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
The other supplemental application is a Category II change providing
for a tolerance of O.1 ppm in uncooked edible tissues in sheep.
Date of Approval: July 9, 2000
NADA 008-622 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Terramycin®, Terramycin -343®
Effect of Supplement: This supplement establishes a zero-day
withdrawal period for swine administered oxytetracycline at
10 mg/lb/day for 14 days.
Date of Approval: April 25, 2001
NADA 008-804 supplemental
approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: TM-50®, TM-100®, TM-50®D, and TM-100®D
Effect of Supplement: This supplement establishes a zero-day
withdrawal period for swine administered oxytetracycline at
10 mg/lb/day for 14 days.
Date of Approval: March 14, 1996
NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: TM-50®, TM-100®, TM-50®D, and TM-100®D
Effect of Supplement: This supplement establishes a zero-day
withdrawal period for swine administered oxytetracycline at
10 mg/lb/day for 14 days.
Date of Approval: April 29, 2002
NADA 008-804 supplemental
approval
Sponsor: Phibro Animal Health
Generic Name: sodium sulfaquinoxaline liquid
Trade Name: TM-50®, TM-50®D, TM-100®, TM-100®D Type A
Medicated Articles
Indications for use: For increased rate of weight gain
and improved feed efficiency; reduction of liver abscesses;
for prevention and treatment of the early stages of shipping
fever complex; the treatment of bacterial enteritis caused by
Escherichia coli and bacterial pneumonia (shipping fever complex)
caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004
NADA 009-576 supplemental
approval
Sponsor: Syntex Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex ; S
Effect of Supplement: This supplement provides for reimplantation
of Synovex ; S at approximately day 70 in steers fed in confinement
for slaughter for additional improvement in rate of weight gain.
Date of Approval: August 19, 1994
NADA 009-576 supplemental
approval
Sponsor: Fort Dodge Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex ; C Synovex ; S
Effect of Supplement:This supplement provides for the
implantation of Synovex C in steers fed in confinement for slaughter
when used as part of a reimplant program where Synovex S is
implanted at approximately day 70 after the initial implantation
of Synovex C.
Date of Approval: July 14, 1998
NADA 010-005 supplemental approval
Sponsor: Fleming Laboratories, Inc.
Generic Name: Piperazine hydrochloride, dipiperazine
sulfate
Trade Name: Wazine; Pig Wormer
Effect of Supplement: This supplemental application provides
for implantation 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 23, 1999
NADA 011-315
supplemental approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX ; 325 Soluble Powder and NEOMIX ;
AG 325 Soluble Powder
Effect of Supplement:The effectiveness neomycin sulfate
was reviewed by the National Academy of Sciences/National Research
Council Drug Efficacy Study Implementation (NAS/NRC DESI) and
has been deemed effective when labeled as specified in the Indications
and Recommended Dosage section of the summary.
Date of Approval: March 4, 1992
NADA 011-315 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name:Neomycin 325/Neomix Ag 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the
target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal
periods to 1 day in cattle, 2 days in sheep, and 3 days for
swine and goats
Date of Approval: April 3, 1996
NADA 011-315
supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX® 325 Soluble Powder; NEOMIX®
AG 325 Soluble Powder
Effect of Supplement: Provides for the use of neomycin
sulfate (NEOMIX325Soluble Powder/NEOMIX® AG 325 Soluable
Powder) in growing turkeys for the control of mortality associted
withEscherichia coli organisms sussceptible to neomycin
sulfate.
Date of Approval: July 9, 1999
NADA 011-427 supplemental
approval
Sponsor: Syntex, Inc.
Generic Name: Estradiol benzoate and testosterone propionate
Trade Name: Synovex-H Heifer Finishing Implants
Effect of Supplement: Supplemental application to provide
for the deletion of the 60-day withdrawal period statement in
the labeling for Synovex-H.
Date of Approval: July 9, 1999
NADA 012-123
supplemental approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: erythromycin
Trade Name: GALLIMYCIN (Erythromycin)INJECTION, 200 mg/mL
Effect of Supplement: One supplemental application is
a Category II change in dosage which was initiated in order
to bring the drug product into compliance with the National
Academy of Science/National Research Council- Drug. Efficacy
Study Implementation (NAS/NRC/DESI) recommendations.The other
supplemental application is a Category II change in tolerance
for drug residues from zero to 0.1 ppm for beef tissues.
Date of Approval: June 30, 1993
NADA 012-491 original approval
Sponsor: Elanco Animal Health, a Division of Eli Lily
and Company
Generic Name:tylosin phosphate
Trade Name: Tylan; Type A medicated article, Tylan; 100
Type A medicated article, Tylan; 100 Cal Type A medicated article
Indications for use: SWINE: For the prevention and/or
control of porcine proliferative enteropathies (ileitis) associated
with Lawsonia intracellularis; 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; and For
the treatment and control of swine dysentery (vibrionic) following
initial medication of TYLAN; in drinking water.
Date of Approval: November 8, 1996
NADA 034-025 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride monohydrate
Trade Name: Lincocin ; Sterile Solution; Lincomix; Injectable
Effect of Supplement: This supplement provides for the
new tolerances for lincomycin in swine and the establishment
of ADI for total residues of lincomycin.
Date of Approval: August 25, 1998
NADA 034-254 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ; 100/200 Premix and MGA ; 500 Liquid
Premix
Effect of Supplement: This supplement provides for the
removal of the requirement for a 48-hour drug withdrawal period
prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994
NADA 034-254
supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Effect of Supplement: This supplement provides for the
use of melengestrol acetate (MGA) in heifers intended for breeding
for suppression of estrus (heat).
Date of Approval: February 18, 1997
NADA 038-200 supplemental
approval
Sponsor: Fermenta Animal Health Company
Generic Name: oxytetracycline hydrochloride
Trade Name: OXY WS (TM) Soluble Antibiotic; MEDAMYCIN
; Soluble Antibiotic
Effect of Supplement:The effectiveness oxytetracycline
HCl soluble powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: July 10, 1993
NADA 038-233
supplemental approval
Sponsor: Pitman-Moore, Inc.
Generic Name: zeranol
Trade Name: RALGRO
Effect of Supplement: This supplement provides for the
deletion of the caution statement in the labeling against the
use of RALGRO ; in heifer (suckling beef) calves intended for
reproduction.
Date of Approval: March 30, 1994
NADA 038-233 supplemental approval
Sponsor: Schering-Plough Animal Health Corp
Generic Name: zeranol
Trade Name: RALGRO ; Magnum
Effect of Supplement: This supplement provides for the
use of an ear implant containing 72 mg zeranol in steers fed
in confinement for slaughter for improved feed efficiency.
Date of Approval: June 25, 1999
NADA 039-077 supplemental
approval
Sponsor: Fermenta Animal Health Company
Generic Names: chlortetracyline (as hydrochloride), sulfathiazole,
penicillin (as procaine penicillin)
Trade Name: CSP(TM) 250 and CSP(TM) 500
Effect of Supplement:The supplemental NADA provides for
revised Type A medicated article, and Type B and C medicated
feed labeling. CSP(TM) can be used from 10 pounds body weight
up to 6 weeks post-weaning.
Date of Approval: December 11, 1995
NADA 039-402 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ; 100/200 Premix and MGA ; 500 Liquid
Premix
Effect of Supplement: This supplement provides for the
removal of the requirement for a 48-hour drug withdrawal period
prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994
NADA 039-402
supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Effect of Supplement: This supplement provides for the
use of melengestrol acetate (MGA) in heifers intended for breeding
for suppression of estrus (heat).
Date of Approval: February 18, 1997
NADA 039-417 supplemental
approval
Sponsor: Rhone-Poulenc, Inc.
Generic Name: decoquinate, Type A medicated article.
Trade Name: Deccox;
Effect of Supplement: This supplement extends to non-ruminating
calves the claim for the prevention of coccidiosis.
Date of Approval: April 12, 1991
NADA 039-417
supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplement adds a new species
(young sheep) to the approved label.
Date of Approval: August 18, 1995
NADA 039-417 supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplemental application provides
for a revised range of concentrations for the use of decoquinate
in cattle, sheep and goats.
Date of Approval: September 4, 2002
NADA 040-209 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: sulfadimethoxine and ormetoprim Type A
medicated article
Trade Name: Rofenaid; 40
Effect of Supplement: This supplemental application provides
for the addition of a new species (chukar partridges).
Date of Approval: April 1, 1999
NADA 041-061 supplemental
approval
Sponsor: Pfizer Animal Health
Generic Name: Carbadox Type A Medicated Article
Trade Name: Mecadox; 10
Effect of Supplement: Provides for the codificaiton of
a revised tolerance for residues of carbadox in edible tissues.
Date of Approval: January 30, 1998
NADA 041-061 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: Carbadox
Trade Name: Mecadox; 10 Type A Medicated Article
Effect of Supplement: Provides for the establishment
of a 42 day slaughter withdrawal period for carbadox in swine
tissues and a limitation against use in pregnant swine or swine
intended for breeding purposes.
Date of Approval: October 5, 1998
NADA 042-841 supplemental
approval
Sponsor: Fort Dodge Laboratories
Generic Name: kanamycin, pectin, bismuth subcarbonate,
activated attapulgite (aluminum magnesium silicate)
Trade Name: Amforol ; Veterinary Oral Tablets
Effect of Supplement: This supplement provides for a
revised formulation for Amforol ; Veterinary Oral Tablets without
aminopentamide hydrogen sulfate. The following issues are addressed:
Date of Approval: February 21, 1991.
NADA 044-759
supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin
Effect of Supplement: 21 CFR 558.95 currently provides
for the use of bambermycins in poultry and swine. This supplement
provides for the use of bambermycins in cattle fed in confinement
for slaughter for increased rate of weight gain and improved
feed efficiency.
Date of Approval: September 21, 1993
NADA 046-592
supplemental approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate
Trade Name: BMD ;
Effect of Supplement: This supplement adds the claim
for the control of clostridial enteritis caused by C. perfringens
in suckling piglets born to sows medicated with BMD.
Date of Approval: April 29, 1991.
NADA 046-592 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD®
Effect
of Supplement: This supplemental application provides for
the addition of a class,replacement chickens, to be added to
the previously approved product.
Date of Approval: June 22, 1998
NADA 046-666 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Procaine G Penicillin
Trade Name: Procaine G Penicillin 50% Type A Medicated
Article
Effect of Supplement: This supplemental application provides
for compliance with theconclusions of the National Academy of
Science/National Research Council(NAS/NRC) evaluation of penicillin-containing
Type A Medicated Articles.
Date of Approval: April 10, 1998
NADA 046-668 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: Procaine G Penicillin
Trade Name: Procaine G Penicillin 50% Type A Medicated
Article
Effect of Supplement: This supplemental application provides
for compliance with theconclusions of the National Academy of
Science/National Research Council(NAS/NRC) evaluation of penicillin-containing
Type A MedicatedArticles.
Date of Approval: April 10, 1998
NADA 046-699 supplemental approval
Sponsor: ALPHARMA, Inc.
Generic Name: Chlortetracycline
Trade Name: ChlorMax
50, ChlorMax65, ChlorMax70 Type A Medicated Article;
Effect of Supplement: This supplemental application adds
the claim for the control of porcine proliferative enteropathies
associated with Lawsonia intracellularis susceptible to chloretetracycline.
Date of Approval: July 7, 2000
NADA 046-718 (Liquid MGA) original
approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA;, Terramycin;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat) and reduction
of liver condemnation due to liver abscesses in heifers fed
in confinement for slaughter.
Date of Approval: May 6, 1998
046-719(Dry MGA) original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA;, Terramycin;
Indfications of use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat) and reduction
of liver condemnation due to liver abscesses in heifers fed
in confinement for slaughter.
Date of Approval: May 6, 1998
NADA 048-271 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Dichlorvos
Trade Name: Task; Tabs
Effect of Supplement: This supplemental application provides
for the use in kittens not less than three months of age, for
the use in adult dogs, and the addition of the 50 and 100 mg
tablet sizes. Also, the list of sponsors is amended to reflect
the sponsors current zip code (64506-2002).
Date of Approval: March 4, 1999
NADA 048-480 supplemental
approval
Sponsor: A D M Animal Health & Nutrition, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name: CHLORATET 50
Effect of Supplement: The effect of this Category II
supplement is to bring the drug product into compliance with
the National Academy of Science/National Research Council/ Drug
Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 048-761 supplemental
approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement: The approval provides for use of Aureomycin
Type A Medicated Article for the control and treatment of specific
diseases in swine, cattle, chickens,turkeys, and sheep.
Date of Approval: February 16, 1996
NADA 048-761 supplemental
approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin
Effect of Supplement: This supplemental approval provides
for a supplemental cattle feed (Moorman's Special Range Minerals
AU Type C Medicated Feed) to provide 0.5-2.0 mg CTC/lb bodyweight/day
for the control of active infection of anaplasmosis caused by
Anaplasma marginale susceptible to chlortetracycline, in grazing
beef cattle (weighing over 700 lbs). The resultant supplemental
feed containing chlortetracycline is offered free-choice continuously
throughout the period in which the cattle are grazing pasture.
Date of Approval: July 9, 1996
NADA 048-761 supplemental
approval
Sponsor: Hoffmann La-Roche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin;
Effect of Supplement: Changes all withdraal times to
zero (0) days when fed at certain doses.
Date of Approval: September 23, 1997
NADA 048-761 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name: Aureomycin; Type A Medicated Article
Effect of Supplement: Deletion of limitations statement,
"Do not feed to chickens producing eggs for human consumption"
and establishment of a Tolerance for chlortetracycline in eggs.
Date of Approval: July 31, 1998
NADA 048-761 supplemental
approval
Sponsor: Roche Vitamins, Inc.
Generic Name:Chlortetracycline
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement: Changes the withdrawal time from
24 hours to zero (0) day withdrawal when chlortetracycline is
fed to chickens at 500 g/ton of feed for 5 days for reduction
of mortality due to Escherichia coli infections susceptible
to chlortetracycline.
Date of Approval: October 26, 1998
NADA 048-761 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name:Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: Provides for top dressing AUREOMYCIN
at the rate of 10 mg chlortetracycline (equivalent to chlortetracycline
hydrochloride) per pound of bodyweight of Type C medicated feeds
for cattle.
Date of Approval: January 24, 2002
NADA 048-761 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name:Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: This supplemental application adds
the claim for the control of porcine proliferative enteropathies
(ileitis) caused by Lawsonia intracellularis susceptible to
chlortetracycline.
Date of Approval: November 15, 2001
NADA 049-287 supplemental
approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: Pfichlor Chlortetracycline Pre-mix
Trade Name: Type A Medicated Article
Effect of Supplement: Category II change.
Date of Approval: July 7, 1993
NADA 055-020 supplemental
approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline bisulfate soluble powder
concentrate
Trade Name: Aureomycin Soluble Powder Concentrate
Effect of Supplement: This supplement upgrades the status
finding of the NAS/NRC from "probably effective" to
"effetive" with respect to the claims regarding control
and treatment of the specifically noted diseases for certain
animals as stated above.
Date of Approval: April 6, 1995
NADA 055-099 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox; Tabs
Effect of Supplement: Provides for additional claim against
canine periodontal infections due to susceptible strains of
aerobic and anaerobic bacteria.
Date of Approval: December 23, 1997
NADA 055-101 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox° Drops
Effect of Supplement: Adds claims for periodontal infections
in dogs.
Date of Approval: December 23, 1997
NADA 065-010 supplemental
approval
Sponsor: Norbrook Laboratories Limited
Trade Name: AQUA-CILLIN
Generic Name: sterile penicillin G procaine suspension,
USP
Effect of Supplement: This supplement provides for the
reduction of the milk withholding period from 72 hours (6 milkings)
to 48 hours.
Date of Approval: July 16, 1992
NADA 065-071 supplemental
approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder
Trade Name: AUREOMYCIN Soluble Powder
Effect of Supplement:The effectiveness chlortetracycline
soluble powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: June 15, 1994
NADA 065-123 supplemental
approval
Sponsor: Pfizer Inc.
Generic Name:tetracycline soluble powder
Trade Name: TETRACYCLINE SOLUBLE POWDER
Effect of Supplement:The effectiveness tetracycline soluble
powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: February 18, 1994
NADA 065-140 supplemental
approval
Sponsor: Wade Jones Company
Generic Name: tetracycline soluble powder
Trade Name: TET-SOL 324
Effect of Supplement:The effectiveness tetracycline soluble
powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: September 15, 1993
NADA 065-252 supplemental
approval
Sponsor: Veterinary Services, Inc.
Generic Name: Strep-SoL
Trade Name: streptomycin sulfate 25% solution
Effect of Supplement:1) The effectiveness streptomycin
sulfate 25% solution was reviewed by the National Academy of
Sciences/National Research Council Drug Efficacy Study Implementation
(NAS/NRC DESI) and has been deemed effective when labeled as
specified in the Indications and Recommended Dosage section
of the summary. 2) Change in tolerance
Date of Approval: September 5, 1993
NADA 065-256 supplemental
approval
Sponsor: Feed Specialties Co.
Generic Name: chlortetracycline soluble powder
Trade Name: Chlortet-Soluble-O
Effect of Supplement:The effectiveness chlortetracycline
soluble powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: October 15, 1993
NADA 065-269 supplemental
approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder
Trade Name: POLYOTIC
Effect of Supplement:The effectiveness tetracycline soluble
powder was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 29, 1993
NADA 065-440 supplemental
approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder concentrate
Trade Name: AUREOMYCIN Soluble Powder Concentrate
Effect of Supplement:The effectiveness chlortetracycline
soluble powder concentrate was reviewed by the National Academy
of Sciences/National Research Council Drug Efficacy Study Implementation
(NAS/NRC DESI) and has been deemed effective when labeled as
specified in the Indications and Recommended Dosage section
of the summary.
Date of Approval: June 15, 1994
NADA 065-441 supplemental
approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder concentrate
Trade Name: POLYOTIC
Effect of Supplement:The effectiveness tetracycline soluble
powder concentrate was reviewed by the National Academy of Sciences/National
Research Council Drug Efficacy Study Implementation (NAS/NRC
DESI) and has been deemed effective when labeled as specified
in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 23, 1993
NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD; Soluble
Effect of Supplement: This supplemental application provides
for the addition of an additional species, growing quail, to
the previously approved product.
Date of Approval: May 27, 1998
NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD; Soluble
Effect of Supplement: This supplemental application provides
for the addition of a new class, replacement chickens, to the
previously approved product.
Date of Approval: February 2, 1999
NADA 065-480 supplemental approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline hydrochloride
Trade Name: Chlortetracycline Soluble Powder
Effect of Supplement: This supplemental application provides
for a revised withdrawal period (from five to zero days) in
swine.
Date of Approval: December 22, 1999
NADA 065-505 original approval
Sponsor: Anthony Products Co.
Generic Name: penicillin G procaine
Trade Name: Microcillin-AG ; ;
Indications for use: Microcillin-AG ; in aqueous suspension
is intended for use in the treatment of the following diseases
when due to penicillin susceptible organisms in cattle, sheep,
swine, and horses. Cattle and Sheep: Microcillin-AG ; is indicated
for the treatment of bacterial pneumonia (shipping fever) caused
by Pasteurella multocida. Swine: Microcillin-AG ; is
indicated for the treatment of erysipelas caused by Erysipelothrix
insidiosa. Horses: Microcillin-AG ; is indicated for the
treatment of strangles caused by Streptococcus equi.
Date of Approval: January 29, 1993
NADA 065-506 original approval
Sponsor: Anthony Products Co.
Generic Name: penicillin G benzathine and penicillin
G procaine.
Trade name: Combicillin ; or Combicillin-AG ;
Indications for use: The prescription product, Combicillin
; is indicated for use in beef cattle, in horses, and in dogs
for bacterial infections due to the following microorganisms
that are susceptible to the serum levels of penicillin common
to this particular dosage form: Pneumonia (shipping fever complex)
caused by Streptococcus spp., Corynebacterium pyogenes,
Staphylococcus aureus; Upper respiratory infections such
as rhinitis or pharyngitis caused by Corynebacterium
pyogenes; Equine strangles caused by Streptococcus
equi; Blackleg caused by Clostridium chauvoei.
Date of Approval: November 8, 1993
NADA 092-286 supplemental
approval
Sponsor:Pfizer, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name:CLCT 10, 20, 30, 50, 70
Effect of Supplement: The effect of this Category II
supplement is to bring the drug product into compliance with
the National Academy of Science/National Research Council/ Drug
Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 092-287 supplemental
approval
Sponsor:Pfizer Inc
Generic Name:chlortetracycline pre-mix milk replacer
Trade Name:CLCT 50 MR & 100 MR
Effect of Supplement: The effect of this Category II
supplement is to bring the drug product into compliance with
the National Academy of Science/National Research Council/ Drug
Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 092-444
supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade name: Rumatel ; 88
Effect of Supplement: This supplement provides for an
additional claim for use of this Type A medicated article to
produce Type C medicated feed for Goats.
Date of Approval: March 17, 1994
NADA 094-170 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Phenylbutazone Tablets
Trade name: Phenylbutazone Tablets USP 200 mg
Effect of Supplement: To provide for a 200 mg phenylbutazone
tablet.
Date of Approval: January 12, 2001
NADA 095-143 original approval
Sponsor: Pfizer Inc.
Generic Name:oxytetracycline dyhydrate pre-mix
Trade Name: OXTC 10, 30, 50, 50-S, 100, 100-S, 100MR
Indications for use: For the control and treatment of
specific diseases susceptible to oxytetracycline dihyrate pre-mix
in swine, calves, cattle, chickens, turkeys, sheep, and honey
bees.
Date of Approval: May 30, 1996
NADA 095-143 supplemental
approval
Sponsor: Phibro Animal Health.
Generic Name:Oxytetracycline Type A Medicated Article
Trade Name: OXTC®-50, OXTC®-100, and OXTC®-200100MR
Effect of Supplement:This supplement establishes a zero-day
withdrawal period for swine administered oxytetracycline at
10 mg/lb/day for 14 days
Date of Approval: April 29, 2002
NADA 095-143 supplemental
approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline
Trade Name: Terramycin® 50, Terramycin® 100, Terramycin®
200 Type A Medicated Articles
Indications for use: For increased rate of weight gain
and improved feed efficiency; reduction of liver abscesses;
for prevention and treatment of the early stages of shipping
fever complex; the treatment of bacterial enteritis caused by
Escherichia coli and bacterial pneumonia (shipping fever complex)
caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004
NADA 095-735
supplemental approval
Sponsor: Elanco Products Company
Generic Name: monensin (as monensin sodium)
Trade name: Rumensin
Effect of Supplement: This supplement provides for an
additional claim for the use of monensin in the prevention and
control of coccidiosis in feedlot cattle.
Date of Approval: October 22, 1990
NADA 095-735 supplemental
approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly
& Co.
Generic Name: monensin sodium
Trade name: Rumensin; 80
Effect of Supplement: This supplemental application provides
for a revision of feeding directions, a weight-based dose for
prevention and control of coccidiosis, and the establishment
of an acceptable daily intake (ADI).
Date of Approval: December 16, 1998
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly
& Co.
Generic Name: monensin sodium
Trade name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: This supplemental application provides
for the addition of a claim for the prevention and control of
coccidiosis caused by Eimeria bovis and E. zuernii.
Date of Approval: July 7, 2000
NADA 095-735 supplemental
approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly
& Co.
Generic Name: monensin sodium
Trade name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: To provide a technical amendment
to 21 CFR 558.355(f)(3)(vii). The improved feed efficiency claim
will be removed from 21 CFR 558.355(f)(3)(vii) and remain separately
codified as it appears in 21 CFR 558.355(f)(3)(i). To provide
for a revision to the Type C medicated feed label for the prevention
and control of coccidiosis caused by Eimeria bovis and Eimeria
zuernii in feedlot cattle, changing the concentration of active
drug ingredient from 10-200 g/ton of monensin to the correct
level of 10 to 30 g/ton of monensin
Date of Approval: December 12, 2003
NADA 096-298 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid
Trade Name: Bovatec;
Indications for use: For increased rate of gain and for
improved feed efficiency in beef cattle fed in confinement for
slaughter.
Date of Approval: August 6, 1982
NADA 096-298 supplemental
approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid
Trade Name: Bovatec
Effect of Supplement: This supplement provides for use
of a Roche formulation of a ruminant free-choice liquid Type
C medicated feed for free-choice supplementation of pasture
cattle.
Date of Approval: July 26, 1993
NADA 096-298
supplemental approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec;
Effect of Supplement: This supplement provides for the
use of Avatec; to prevent coccidiosis caused by Eimeria legionensis
in chukar partridges.
Date of Approval: April 19, 1995
NADA 096-298 supplemental
approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid sodium
Trade Name: AVATEC
Effect of Supplement:Adds an additional claim for the
prevention of coccidiosis in growing turkeys with a zero (0)
day withdrawal time. The use level in feeds approved for broiler
chickens at 68 to 113 grams per ton of feed (75-125 ppm) remains
the same
Date of Approval: April 28, 1995
NADA 096-298 supplemental
approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec;
Effect of Supplement: This supplement adds an additional
claim for the prevention of coccidiosis in young rabbits.
Date of Approval: October 20, 1995
NADA 096-298 supplemental
approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec; Type A Medicated Article
Effect of Supplement: This supplement provides for the
addition of a species and class (young rabbits) at a new lower
concentration.
Date of Approval: February 5, 1999
NADA 096-298 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Avatec®
Effect of Supplement: This supplement provides for establishing
tolerances for residues in chickens, turkeys and sheep liver
and adding an acceptable daily intake (ADI).
Date of Approval: February 20, 2001
NADA 096-298 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Bovatec®
Effect of Supplement: This supplement, 21 CFR 558.311,
currently provides for the use of lasalocid (1) to improve feed
efficiency and increase rate of weight gain in cattle fed in
confinement for slaughter, (2) to increase rate of weight gain
in pasture cattle (slaughter, stocker, feeder cattle, and dairy
and beef replacement heifers) when fed daily in at least one
pound of supplemental feed, and (3) to increase rate of weight
gain in pasture cattle (slaughter, stocker, feeder cattle, and
dairy and beef replacement heifers) when lasalocid is provided
in a free-choice supplemental feed. .
Date of Approval: July 25, 2001
NADA 096-298 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Bovatec®
Effect of Supplement: To provide for the use of lasalocid
in a generic free-choice high-phosphorus loose mineral feed
containing 1088 grams of lasalocid per ton feed.
Date of Approval: April 9, 200
NADA 097-452 supplemental
approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Oxyject; 100
Effect of Supplement: This supplemental NADA provides
for the subcutaneous route of administration and the application
of new tolerances (61 FR 67435) to the approved product, Oxyject;
100.
Date of Approval: February 21, 1997
NADA 097-505 supplemental approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Premixes
Effect of Supplement: This supplement provides for the
following actions concerning use of Lincomycin in swine feed
at the 40 and 20-gram-per-ton levels: (1) removal of the 6-day,
preslaughter, drug withdrawal requirement; and (2) removal of
the Lincomycin entry from the Category II table and addition
of same to the Category I table in 21CFR 558.4.
Date of Approval: May 1, 1990
NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride monohydrate
Trade Name: Lincomycin; 10/20/50 Feed Medications
Effect of Supplement: Swine - For treatment of swine
dysentery. For treatment and control of swine dysentery. For
reduction of severity of mycoplasmal pneumonia. For increase
in rate of gain in growing-finishing swine. Broiler chickens--For
increase of rate of weight gain and feed efficiency. For the
control of necrotic enteritis.
Date of Approval: August 25, 1998
NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride
Trade Name: Lincomycin® 20/50
Effect of Supplement: To add the label claim for the
control of porcine proliferative enteropathies (ileitis) caused
by Lawsonia intracellularis.
Date of Approval: February 28, 2002
NADA 098-341 original approval
Sponsor: American Hoechst Corporation, Animal Health
Division
Generic Name:bambermycins, roxarsone, monensin
Trade Name: Flavomycin;, 3-Nitro, Coban
Indications for use: For the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima,
E. mivati, E. brunetti; For increased rate of weight gain in
broiler chickens
Date of Approval: March 4, 1985
NADA 100-901 supplemental
approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline pre-mix
Trade Name: Pfichlor 100S Milk Replacer Type A Medicated
Article
Effect of Supplement: Category II change.
Date of Approval: January 27, 1998
NADA 100-929 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: sulfadimethoxine/ormetoprim
Trade Name: Primor Tablets
Indications for use: Primor is to be used in the treatment
of skin and soft tissue infections (wounds and abscesses) in
dogs caused by strains of Staphylococcus aureus and Escherichia
coli susceptible to sulfadimethoxine/ormetoprim.
Date of Approval:November 24, 1989
NADA 100-929 supplemental
approval
Sponsor:Pfizer Inc.
Generic Name:sulfadimethoxine/ormetoprim
Trade Name:Primor;
Effect of Supplement:This supplemental Application amends
the NADA to provide for the use of Primor; Tablets for the treatment
of urinary tract infections caused by certaom bacteroa susceptible
to sulfadimethoxine/ormetoprim. Primor; Tablets (NADA 100-929)
is currently approved for use in dogs.
Date of Approval: August 5, 1996
NADA 101-331 original approval
Sponsor Name: Ralston Purina Co.
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Indications for use: For the removal of large roundworms
(ascarids), Toxocara canis and Toxascaris leonina
and hookworms, Anyclostoma caninum and Uncinaria
stenocephala in dogs. The presence of these parasites should
be confirmed by laboratory fecal examination. Consult your veterinarian
for assistance in the diagnosis, treatment and control of parasitism.
Date of Approval: November 14, 1978.
NADA 101-331 supplemental approval
Sponsor: Ralston Purina Company
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Effect of Supplement: Will provide for repeat treatment
of puppies, lactating bitches and adult dogs for control of
T. canis.
Date of Approval:
NADA 101-479 supplemental
approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an
additional species, cattle, to be added to the previously approved
product, BANAMINE® Injectable Solution.
Date of Approval: May 5, 1998
NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an
additional statement added to the Precaution section of the
labeling and a heading change on the label from Warning to Adverse
Reactions to the previously approved product labeling for BANAMINE®
Injectable Solution.
Date of Approval: May 6, 1998
NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement allows for use in lactating dairy cattle for the existing indications of “the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.” Additionally, it allows for a new indication “for the control of pyrexia associated with acute bovine mastitis” and it establishes a tolerance for residues of flunixin in milk.
Date of Approval: August 19, 2004
NADA 101-862 supplemental
approval
Sponsor: Schering-Plough Animal Health
Generic Name: gentamicin sulfate veterinary
Trade Name: GARASOL; Injection
Effect of Supplement: This supplement provides for adding
the previously approved turkey claims under NADA 47-486 to the
labeling of NADA 101-862. The excipients in the formulations
are identical, although the quantities are slightly different.
Date of Approval: March 28, 1996
NADA 104-646 original approval
Sponsor: Elanco Products Company
Generic Name: monensin sodium; Tylosin Phosphate
Trade Name: RUMENSIN; TYLAN ;
Indications for use: For improved feed efficiency and
for reduction of incidence of liver abscesses in beef cattle
caused by Sphaerophorus necrophorus and Corynebacterium
pyogenes .
Date of Approval: March 6, 1976
NADA 104-646 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the complete range
of both individually approved drugs (Type A Medicated Articles)
in Type B or C medicated feeds in combination for cattle fed
in confinement for slaughter.
Date of Approval: November 19, 1998
NADA 104-646 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the treatment of the
approved combination of monensin plus tylosin to be treated
as a combination under the provisions of the Animal Drug Availability
Act of 1996, and its reference to feed delivered drug combinations.
Date of Approval: February 2, 2001
NADA 106-964
original approval
Sponsor: Elanco Products Company
Generic Name: apramycin sulfate
Trade Name: APRALAN; Soluble Powder
Indications for use: APRALAN; Soluble Powder is indicated
for the oral treatment of porcine colibacillosis (weanling pig
scours) caused by strains of E. coli sensitive to apramycin.
Date of Approval: November 20, 1981
NADA 106-964 supplemental
approval
Sponsor: Elanco Products Company
Generic Name: apramycin sulfate
Trade Name: APRALAN; Soluble Powder
Effect of Supplement: Dosage level of 12.5 mg/kg bodyweight
(5.7 mg/lb bdwt) daily for 7 days and indications for the control
of porcine colibacillosis.
Date of Approval: November 23, 1983
NADA 106-964 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: Apralan;
Effect of Supplement: Assigns an increased acceptable
daily intake (ADI) and an increased safe concentration for total
apramycin residues in edible tissues.
Date of Approval: June 24, 1997
NADA 107-996 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, bacitracin methylene
disalicylate
Trade Name: Avatec® plus BMD®
Effect of Supplement: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E.
brunetti, E. mivati, an E, maxima, and for increased rate
of weight gain and improved feed efficiency in broiler and fryer
chickens.
Date of Approval: December 4, 2002
NADA 110-048
original approval
Sponsor: SmithKline Animal Health Products
Generic Name: albendazole
Trade Name: Valbazen;
Indications for use: Cattle anthelmintic for the removal
and control of endoparasites infecting cattle.
Date of Approval:March 30, 1989.
NADA 110-048 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Albendazole
Trade Name: Valbazen;
Effective Supplement: Provides for the addition of a
new species (sheep) at the more concentrated cattle formulation.
Date of Approval:December 02, 1998
NADA 110-315 supplemental
approval
Sponsor: Ivy Laboratories, Inc.
Generic Name:progesterone plus estradiol benzoate
Trade Name: CALF-oid
Effect of Supplement: This supplement provides for the
use of CALF-oid in suckling beef calves (at least 45 days of
age) up to 400 lbs. of bodyweight.
Date of Approval:April 5, 1990.
NADA 110-315
supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone and estradiol benzoate
Trade Name: Implus-C;
Effect of Supplement: This supplement provides for the
deletion of the present labeling limitation against the use
of Implus-C in heifer (suckling beef) calves intended for reproduction.
Date of Approval: January 22, 1997
NADA 110-315 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone, estradiol benzoate and and
Tylosin Tartrate
Trade Name: Component; E-S with Tylan;; Component; E-C
with Tylan;
Indications for use: Component; E-S with Tylan; : For
increased rate of weight gain and improved feed efficiency in
steers weighing 400 lbs or more. Component; E-C with Tylan;
: For increased rate of weight gain in suckling beef calves
up to 400 lbs body weight.
Date of Approval: July 20, 1999
NADA 111-607 supplemental
approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit; 5.68% Injectable Solution
Effect of Supplement: This Supplemental Application amends
the NADA to provide for the use of Droncit Injectable Solution
against Echinococcus multilocularis in dogs.
Date of Approval:July 16, 1993
NADA 111-636 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplement provides for use
of this product in broiler chickens. It also provides for the
deletion of the tolerance for lincomycin residues in chickens.
Date of Approval: January 23, 1990
NADA 111-636 supplemental
approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride monohydrate
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplemental approval provides
for the assignment of a tolerance of 0.6 ppm for lincomycin
in swine liver, a tolerance of 0.1 ppm for lincomycin in swine
muscle, and the assignment of an Acceptable Daily Intake (ADI)
of 25 micrograms per kilograms per body weight per day for the
total residues of lincomycin. In addition, this supplement reduces
the slaughter period for drinking water uses of lincomycin in
swine from 6 days to 0 days.
Date of Approval: August 25, 1998
NADA 111-636 supplemental
approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: Provides for revision of
the approved LINCOMIX Soluble Powder Insert Labeling replacing
a caution for use only in swine weighing less than 250 pounds
with a caution indicating safety has not been demonstrated for
pregnant swine or swine intended for breeding.
Date of Approval: December 31, 2001
NADA 111-798 supplemental
approval
Sponsor: Mobay Corporation, Animal Health Division
Generic Name: praziquantel
Trade Name: CUTTER Tape-Tabs
Effect of Supplement: The purpose of the supplement is
to provide for OTC marketing of praziquantel tablets for the
indications listed below.
Date of Approval: January 18, 1990
NADA 111-798 supplemental
approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit* Feline Cestocide Tablets
Effect of Supplement: This supplement amends the NADA
to provide for a 11.5 mg spherical tablet, which is half the
concentration of the previously approved 23 mg tablet, for cats.
Date of Approval: January 11, 1993
NADA 111-798 supplemental
approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit; 34 mg Canine Tablets
Effect of Supplement: This Supplemental Application amends
the NADA to provide for the use of Droncit Tablets against Echinococcus
multilocularis in dogs. Droncit Tablets (NADA #111-798,
46 FR 60570 [December 11, 1981]) are currently approved for
use in dogs and cats.
Date of Approval: July, 16, 1993
NADA 112-051 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Levamisole hydrochloride
Trade Name: Levasole ®
Effect of Supplement: Used for the following adult nematode
infections:
Sheep:
Stomach Worms: Haemonchus contortus, Trichostrongylus axei,
Teladorsagia circumcincta.
Intestinal Worms: Trichostrongylus colubriformis, Cooperia
curticei, Nematodirus spathiger, Bunostomum trigonocephalum,
Oesophagostomum columbianum, Chabertia ovina.
Lungworms:Dictyocaulus
filaria.
Cattle:
Stomach Worms: Haemonchus placei, Ostertagia
ostertagi, Trichostrongylus axei.
Intestinal Worms: Trichostrongylus longispicularis,
Cooperia oncophora, Cooperia punctata, Nematodirus spathiger,
Bunostomum phlebotomum, Oesophagostomum radiatum.
Lungworms:Dictyocaulus
viviparus.
Date of Approval: December 23, 2003
NADA 113-232
supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Liquamycin; LA-200;
Effect of Supplement: This supplement provides for the
codification of a revised tolerance for residues of oxytetracycline
in edible tissues.
Date of Approval: March 28, 1996
NADA 113-232 supplemental
approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Terramycin-10, 20, 50, 50D, 100, 100D, 100SS,
& 200
Effect of Supplement: This supplement provides for changes
to the product labeling to include a subcutaneous (SC) route
of administration in cattle. Also, the indications section of
the labeling will be revised to include "pre-ruminating
(veal) calves."
Date of Approval: April 23, 1997
NADA 113-232
supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Liquamycin; LA-200;
Effect of Supplement: This supplement provides for changes
to the product labeling to include lactating dairy cows. Also,
a tolerance for oxytetracycline in milk is established at 0.3ppm.
Date of Approval: July 21, 1998
NADA 115-581 supplemental approval
Sponsor: MoorMan's, Inc
Generic Name: Monensin Sodium
Trade Name: Rumensin®
Effect of Supplement: This supplement provides for the
addition of the claim "for the prevention and control of
coccidiosis caused by Eimeria bovis and E. zuernii" to
MoorMan's Type C monensin medicated free-choice protein-mineral
blocks (MoorMan's Mintrate Blonde Block RU and MoorMan's Mintrate
Red Block RU).
Date of Approval: September 27, 2001
NADA 116-088 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate, monensin,
roxarsone
Trade Name: BMD;/Coban;/3-Nitro;
Effect of Supplement: This supplemental application adds
the higher use level of bacitracin methylene disalicylate in
broiler chicken feed (100 to 200 grams/ton) associated with
the necrotic enteritis control claim which was approved under
the single ingredient application (NADA 046-592).
Date of Approval: December 24, 1998
NADA 118-980 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly
& Co.
Generic Name: Narasin
Trade Name: Monteban®
Effect of Supplement: This supplement provides for the
revision of 21 CFR 556.428 by the addition of tolerance for
abdominal fat and acceptable daily intake (ADI)
Date of Approval: April 11, 2001
NADA 120-161 supplemental approval
Sponsor: Pharmacia & Upjohn Co
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE Capsules
Effect of Supplement: The supplement provides for the
use of clindamycin hydrochloride (ANTIROBE Capsules) in dogs
at a dose range of 2.5-15 mg/lb body weight every 12 hours for
skin infections (wounds and abscesses), deep wounds and abscesses,
and dental infections. It also provides for a dose range in
dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition,
this supplement provides for the addition of a 300 mg capsule.
This supplement also provides for the addition of recent MIC
data derived from U.S. diagnostic laboratories.
Date of Approval: May 13, 2002
NADA 120-614 original approval
Sponsor: Webel Feeds, Inc.
Generic Name: Tylosin (as tylosin phosphate) combined
with Sulfamethazine
Tradename: Tylan 5, 10, 20, and 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)
Date of approval: May 28, 1985
NADA 120-648 supplemental
approval
Sponsor: Hoechst Roussel Vet
Generic Name: fenbendazole
Trade Name: Panacur ; and Safe-Guard;
Date of approval: May 28, 1985
NADA 121-473 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Panacur®; 22.2% Granules
Effect of Supplement: This supplement provides a claim
as an anthelmintic in the following species within the families
Felidae and Ursidae: lion (Panthera leo),
tiger (Panthera tigris) cheetah (Acinonyx jubatus)
Puma (Felis concolor), Jaguars (Panthera onca),
Leopard (Panthera pardus), Panther (Panthera spp)
Grizzly Bear (Ursus horribilis), Polar Bear (Ursus
maritimus), and Black Bear (Ursus americanus).
Date of Approval: May 31, 1994
NADA 121-473 supplemental approval
Sponsor: Intervet Inc.
Generic Name: fenbendazole
Trade Name: PANACUR®-C
Effect of Supplement: This supplement provides for a
change from prescription (Rx) to OTC status for fenbendazole
granules 22.2% packets to be marketed under the trade name PANACUR®-C.
The jar presentation (Panacur®) will remain prescription
(Rx) as it is also labeled for use in other species of carnivorous/omnivorous
animals. The jar presentation will continue to be marketed
under the Panacur® trade name.
Date of Approval: March 19, 2002
NADA 122-578 supplemental
approval
Sponsor: Anika Therapeutics, Inc.
Generic Name:Hyaluronate sodium
Trade Name: Hyvisc; Sterile Injection
Effect of Supplement:To increase the concentration of
hyaluronate sodium from 10 mg/mL to 11 mg/mL, and increase the
dose from 20 mg to 22 mg for small joints and from 40 mg to
44 mg for large joints.
Date of Approval: September 30, 1998
NADA 124-309 supplemental
approval
Sponsor Name: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA 100/200 Premix or MGA 500 Liquid Premix
and Rumensin
Effect of Supplement: This supplement provides for removal
of the requirement for a preslaughter drug withdrawal period
for heifers fed melengestrol acetate in combination with monensin.
Previous approvals have required a 48-hour preslaughter drug
withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994
NADA 124-309 supplemental
approval
Sponsor Name: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently
provides for the combination use of melengestrol acetate and
monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate
and 50 to 360 mg/hd/day monensin for heifers being fed in confinement
for slaughter for increased rate of weight gain, improved feed
efficiency and suppression of estrus (heat).These supplements
provide for the treatment of the approved combination of melengestrol
acetate and monensin to be treated as a combination under the
provisions of the Animal Drug Availability Act of 1996, and
its reference to feed delivered drug combinations. This effect
is to provide for the addition of the claim for prevention and
control of coccidiosis on a mg/lb body weight basis for monensin
to this combination with melengestrol acetate for Type B and
Type C medicated feeds for heifers being fed in confinement
for slaughter.
Date of Approval: February 26, 2002
NADA 125-476 supplemental
approval
Sponsor Name: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA 100/200 Premix or MGA 500 Liquid Premix
and Rumensin
Effect of Supplement: This supplement provides for removal
of the requirement for a preslaughter drug withdrawal period
for heifers fed melengestrol acetate in combination with monensin.
Previous approvals have required a 48-hour preslaughter drug
withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994
NADA 125-476 supplemental
approval
Sponsor Name: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently
provides for the combination use of melengestrol acetate and
monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate
and 50 to 360 mg/hd/day monensin for heifers being fed in confinement
for slaughter for increased rate of weight gain, improved feed
efficiency and suppression of estrus (heat).These supplements
provide for the treatment of the approved combination of melengestrol
acetate and monensin to be treated as a combination under the
provisions of the Animal Drug Availability Act of 1996, and
its reference to feed delivered drug combinations. This effect
is to provide for the addition of the claim for prevention and
control of coccidiosis on a mg/lb body weight basis for monensin
to this combination with melengestrol acetate for Type B and
Type C medicated feeds for heifers being fed in confinement
for slaughter.
Date of Approval: February 26, 2002
NADA 126-050 supplemental
approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: Apralan;75
Effect of Supplement: Increases acceptable daily intake
and safe residue concentration levels in edible tissues.
Date of Approval: June 24, 1997
NADA 128-070 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: Albendazole
Trade Name: VALBAZEN;
Indications for Use: Cattle anthelmintic for the removal
and control of the following endoparasites and infecting cattle:
A. Liver flukes:Fasciola hepatica (adults) B.
Tapeworms:Moniezia benedeni, M. expansa (heads and
segments) C. Lungworms:Dictyocaulus viviparus
(adults and 4th stage larvae) D. Stomach worms: Barberpole
worm: Haemonchus contortus, H. placei (adults and 4th
stage larvae) Brown stomach worm: Ostertagia ostertagi
(adults, 4th stage larvae and 4th stage inhibited larvae) Small
stomach worm: Trichostrongylus axei (adults and 4th stage
larvae) E. Intestinal worms: Hookworm: Bunostomum
phlebotomum (adults) Threadnecked intestinal worm: Nematodirus
spathiger, N. helvetianus (adults and 4th stage larvae)
Small intestinal worm: Cooperia oncophora, C. punctata
(adults and 4th stage larvae) Bankrupt worm: T. colubriformis
(adults) Nodular worm: Oesophagostomum radiatum (adults)
Date of Approval: November 17, 1989
NADA 128-255 original approval
Sponsor: Kay Dee Feed Co.
Generic Name: tylosin, sulfamethazine
Trade Name: Tylan 5 Sulfa Premix, Tylan 10 Sulfa Premix
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 Corynebacterium pyogenes ). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: February 19, 1982
NADA
128-409 supplemental approval
Sponsor Name:MERCK & CO., INC.
Generic Name:Ivermectin
Trade Name:IVOMEC; Injection for Cattle
Effect of Supplement: New tolerance for residues of ivermectin
B1a in cattle liver of 100 ppb and revised safe concentration
in tissues
Date of Approval: September 13, 1995
NADA 128-409 supplemental
approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and Swine
Effect of Supplement: New claims for persistent control
of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: February 24, 1997
NADA 128-409 supplemental
approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and
Swine
Effect of Supplement: New claim for the treatment and
control of grubs (Hypoderma bovis in American bison.
Date of Approval: December 19, 1997
NADA 128-409 supplemental
approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and Swine
Effect of Supplement: This supplemental application extends
the period of persistent effect against infections of Dictyocaulus
viviparus from 21 days to 28 days after treatment, and establishes
an ADI in cattle muscle for total residues of ivermectin
Date of Approval: April 1, 1999
NADA 128-409 supplemental
approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC (ivermectin) Injection for Cattle
and Swine
Effect of Supplement: To extend the persistent effect
periods of 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: August 16, 2004
NADA 128-620 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Generic Name:Panacur
Effect of Supplement: This supplement provides for an
expanded use of fenbendazole in a new species (goats).
Date of Approval: April 25, 1994
NADA 128-620 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: Fenbendazole
Trade Name: Safe-Guard; 10% Suspension
Effect of Supplement: This supplement provides for the
use of fenbendazole for the removal and control of gastrointestinal
parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996
NADA 128-620
supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: Fenbendazole
Trade Name: Panacur®,
Safe-guard® Suspension 10%
Effect of Supplement: This supplement provides for establishing
tolerances for residues of parent fenbendazole in muscle of
cattle and goats.
Date of Approval: May 9, 2000
NADA 128-620
supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: Fenbendazole
Trade Name: Panacur®,
Safe-guard® Suspension 10%
Effect of Supplement: 1) The marketing status of fenbendazole
suspension for use in goats is changed from prescription (Rx)
to over-the-counter (OTC) by removing goats from the PanacurÆÊ
Suspension 10% label and by adding goats to the Safe-GuardR
Suspension 10% label. The formulation of the two products is
identical. 2) The indications for use in goats are revised from
"for the removal and control of stomach and intestinal
worms Haemonchus contortus and Ostertagia circumcincta"
to "for the removal and control of stomach worms (adults)
Haemonchus contortus and Teladorsagia circumcincta.¨
Date of Approval: February 13, 2003
NADA 128-686
supplemental approval
Sponsor: Agri-Bio Corporation
Generic Name: salinomycin sodium
Trade Name: Bio-Cox;
Date of Approval: September 1, 1994
NADA 128-686 supplemental
approval
Sponsor: Hoffmann-La Roche
Generic Name: salinomycin sodium
Trade Name: Bio-Cox;
Effect of Supplement: To add roaster and replacement
(breeder and layer) chickens to the label claim for the prevention
of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti,
and E. mivati.
Date of Approval: February 3, 1997
NADA 130-435 supplemental
approval
Sponsor: I.D. Russell Company, Laboratories
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTET SOLUBLE
Effect of Supplement: This supplement provides for use
of this product in swine.
Date of Approval: December 10, 1993
NADA 130-435 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytet Soluble, Tetravet-CA
Effect of Supplement: This supplement provides for a
revised withdrawal time of oxytetracycline hydrochloride soluble
powder in the drinking water of turkeys and swine.
Date of Approval: November 29, 2000
NADA 130-435 supplemental
approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OxyMarine
Effect of Supplement: To add a claim for the marking
of skeletal marking of tissues of all finfish fry and fingerlings
Date of Approval: December 24, 2003
NADA 130-736 supplemental
approval
Sponsor: Elanco Products Company
Generic Name: monensin
Trade Name: COBAN;
Effect of Supplement: This supplemental NADA (130-736)
provides for a change in treatment regimen from a ten-week feeding
period to a continuous feeding for growing turkeys.
Date of Approval: March 23, 1990
NADA 130-951 supplemental
approval
Sponsor: Roussel Uclaf, Div. Agro-Veterinaire
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol;
Effect of Supplement: Change of tolerance.
Date of Approval: March 8, 1991
NADA 130-951
supplemental approval
Sponsor: Roussel-Uclaf
Generic Name: halofuginonc hydrobromide
Trade Name: STENOROL;
Effect of Supplement: This supplemental submission has
been filed to provide for the same dose level of 2.72 g/t (3
ppm) to be fed to replacement cage laying chickens and replacement
broiler breeder chickens for the prevention of coccidiosis caused
by Eimeria tenella, E. necatrix, E. aacervulina, E. maxima,
E. brunetti, and E. mivati / mitis.
Date of Approval: September 19, 1994
NADA 131-310 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: altrenogest
Trade Name: Regu-Mate; for Horses
Effect of Supplement: This supplement provides for label
and package insert changes. This supplement does not affect
the status of the original approval and Regu-Mate; (altrenogest)
remains a "by prescription only" product.
Date of Approval: June 20, 1990
NADA 131-392
original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name:ivermectin
Trade Name: Ivomec; Liquid for Sheep
Indications for use: For the control of certain gastrointestinal
nematodes, lungworms, and nasal bots in sheep.
Date of Approval: July 26, 1988
NADA 131-675
supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD; (Premix)
Effect of Supplement:This supplement provides for an
additional Type A medicated article (premix) containing 8% fenbendazole
for the same indications for use in Type C medicated swine feed
as the currently approved Type A medicated articles containing
4% and 20% fenbendazole. See 21 CFR 558.258.
Date of Approval: March 30, 1991
NADA 131-675
supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard ;
Effect of Supplement: This supplemental approval provides
for the minor use
claim as a dewormer in specific hoofed zoo and wildlife animals.
Date of Approval: November 20, 1990
NADA 131-675 supplemental
approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard® (fenbendazole)
Effect of Supplement: This supplement provides for the
revision 21 CFR 556.275 by establishing tolerances for residues
in swine liver and muscle and adding allowable daily intake
(ADI).
Date of Approval: February 10, 2000
NADA 131-675 supplemental
approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement provides for the
addition of growing turkeys to the previously approved SAFE-GUARD®
Type A medicated article labeling.
Date of Approval: July 3, 2000
NADA 131-675 supplemental
approval
Sponsor: Intervet, Inc.
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement to NADA 131-675
provides for a new claim for control of gastrointestinal worms
in horses [large strongyles (Strongylus edentatus, S. equinus,
S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum
spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (Oxyuris
equi), and ascarids (Parascaris equorum)].
Date of Approval: March 14, 2003
NADA 132-337 supplemental
approval
Sponsor: Miles, Inc.
Generic Name: cythioate
Trade Name: Proban ; 90 mg tablets
Effect of Supplement: This supplement amends the NADA
to provide for a 90 mg tablet and minor labeling changes. The
currently approved tablet is 30 mg.
Date of Approval: April 25, 1994
NADA 132-872
supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard; Paste 10%; Panacur; Paste 10%
Effect of Supplement: This supplement provides for the
use of fenbendazole for the removal and control of gastrointestinal
parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996
NADA 133-953 supplemental
approval
Sponsor: Mobay Corporation
Generic Name: Febantel and Praziquantel
Trade Name: Vercom Paste Anthelmintic
Effect of Supplement: This supplement provides for the
addition of the following warning statement to the label: "Warning:
Consider alternative therapy or use with caution in animals
with pre-existing liver or kidney dysfunction."
Date of Approval: September 12, 1991
NADA 134-314 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: EQVALAN® Paste 1.87%
Effect of Supplement:The supplement provides for the
use of ivermectin paste for the treatment and control of Craterostomum
acuticaudatum, Petrovinema poculatum, and Coronocyclus spp.
including: Coronocyclus coronatus, and Coronocyclus labratus.
Also, the label descriptions of some currently-approved parasite
genera are being revised to add included species for which data
already exists in the NADA file and to reflect changes in scientific
nomenclature.
Date of Approval: April 2, 2003
NADA 134-314 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: EQVALAN® Paste 1.87%
Effect of Supplement: This supplement amends the EQVALAN (ivermectin) Paste 1.87% labeling to reflect a change in the indications section. Specifically, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from the fourth-stage larvae.
Date of Approval: August 9, 2004
NADA 134-779 supplemental
approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade Name: Paratect Flex(TM)
Effect of Supplement:This supplemental application provides
an additional dosage form for the Morantel tartrate cartridge
(Paratect Cartridge) which has been approved since 1984 under
this same NADA.
Date of Approval: March 25, 1991
NADA 134-830 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin zinc, monensin sodium
Trade Name: Albac;, Coban;
Indications For Use: As an aid in prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E.
brunetti, E. maxima and E. mivati; for increased
rate of weight gain, and for improved feed efficiency in broiler
chickens.
Date of Approval: September 1, 1992
NADA 135-321 supplemental
approval
Sponsor: Roche Vitamins & Fine Chemicals
Generic Name: salinomycin sodium, bacitracin methylene
disalicylate, roxarsone
Trade Name: Bio-Cox;, BMD;, 3-Nitro;
Effect of Supplement: Category II supplemental change
providing for an additional use level of roxarsone.
Date of Approval: May 5, 1997
NADA 135-906
supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health,
Inc.
Generic Name: Testosterone propionate, estradiol benzoate,
tylosin tartr
Trade Name: Component; E-H with Tylan;
Effect of Supplement: This supplement provides for the
use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for
new indications.
Date of Approval: July 20, 1999
NADA 135-940 supplemental approval
Sponsor: Pharmacia and Upjohn
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE AQUADROPS Liquid
Effect of Supplement: The supplement provides for the
use of clindamycin hydrochloride (ANTIROBE AQUADROPS Liquid)
in dogs at a dose range of 2.5-15 mg/lb body weight every 12
hours for skin infections (wounds and abscesses), deep wounds
and abscesses, and dental infections. It also provides for a
dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis.
In addition, this supplement provides for an expanded dose range
of 5-15 mg/lb every 24 hours in cats. This supplement also provides
for the addition of recent MIC data derived from a survey of
U.S. diagnostic laboratories.
Date of Approval: May 13, 2002
NADA 135-940 supplemental
approval
Sponsor: Pharmacia and Upjohn
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: ANTIROBE AQUADROPS
Effect of Supplement: This supplement provides for the
use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for
new indications.
Date of Approval: October 7, 1996
NADA
135-940 supplemental approval
Sponsor: The Upjohn Co
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: Antirobe Aquadrops
Effect of Supplement: This supplemental application provides
for the following additional claims: Aerobic bacteria: for the
treatment of dental infections caused by susceptible strains
of Staphylococcus aure us. Anaerobic bacteria: for the
treatment of soft tissue infections (deep wounds and abscesses),
dental infections, and osteomyelitis caused by or associated
with susceptible strains of Bacteroides fragilis, Bacteroides
melaninogenicus, Fusobacterium necrophorumand Clostridium
perfringens.
Date of Approval: November 16, 1989
NADA 136-483 supplemental
approval
Sponsor: Norden Laboratories
Generic Name: diethylcarbamazine citrate and oxibendazole
chewable tablets
Trade Name: Filaribits; Plus Chewable Tablets
Effect of Supplement: Results in the addition of a label
statement to provide for the removal and control of mature and
immature stages of intestinal Toxocara canis (ascarid
infection). Adequate data showing efficacy for the additional
use has been submitted in the supplemental application which
is the subject of this approval.
Date of Approval: January 18, 1989
NADA 136-742 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Clorsulon
Trade Name: Curatrem® Drench
Effect of Supplement: This supplement provides for the
revision of 21 CFR 556.163 by the addition of tolerance in muscle
of cattle and acceptable daily intake (ADI) and deletion of
safe concentrations.
Date of Approval: May 16, 2001
NADA 137-537 original approval
Sponsor: A.H. Robins Company
Generic Name: salinomycin and lincomycin
Trade Name: Bio-Cox and Lincomix;
Indications For Use: Anticoccidial and Growth Promotant.
Note: This application provides for the combined use of two
currently approved Type A medicated articles in the manufacture
of Type C medicated feeds for broiler chickens.
Date of Approval: May 22, 1989
NADA 137-600 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD(TM)
Effect of Supplement: The original approval for this
NADA provided for the use of Type A Medicated Article in complete
feeds for cattle for the removal and control of the listed parasites.
The Type "C" medicated complete feed was fed as a
single dose of 5 mg fenbendazole per kilogram of body weight.
This supplemental submission has been filed to provide for that
same dosage of 5 mg/kg body weight to be fed free-choice in
a vitamin/mineral supplement (Type C feed) administered over
a three to six day period for the removal and control of the
listed parasites
Date of Approval: August 30, 1989
NADA 137-600
supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard; 20% Type "A" Medicated
Article (Premix) 0.5% Cattle Top Dress 35% Free-Choice Mineral
Effect of Supplement: This supplement provides for the
use of fenbendazole for the removal and control of gastrointestinal
parastites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996
NADA 137-687 supplemental approval
Sponsor: Natchez Animal Supply Company
Generic Name: Formalin, approximately 37% by weight of
formaldehyde gas
Trade Name: FORMALIN-F™
Effect of Supplement: Provides for the use of FORMALIN-Fä
to be expanded, as a parasiticide, to all finfish and penaeid
shrimp, and, as a fungicide, to the eggs of all finfish
Date of Approval: November 25, 2002
NADA 138-187 original approval
Sponsor: Micro Chemical, Inc.
Generic Name: Tylosin (as tylosin phosphate)
Trade Name: Tylan 10, 40 and 100 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
of 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: August 6, 1985
NADA 138-255 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: iron hydrogenated dextran injection
Trade Name: Iron Hydrogenated Dextran Injection
Incations for use: For the prevention and treatment of
anemia due to iron deficiency in baby pigs.
Date of Approval: August 6, 1985
NADA 138-342 original approval
Sponsor: Feed Service Co., Inc.
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 Corynebacterium pyogenes). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: June 11, 1985
NADA 138-405 original approval
Sponsor: Anthony Products Company
Generic Name: pyrilamine maleate injection
Trade Name: Pyrilamine Maleate Injection
Indications for use: For use in horses for treatment
of conditions in which antihistaminic therapy may be expected
to lead to alleviation of some signs of disease, such as laminitis.
Date of Approval: November 17, 1986
NADA 138-412 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin tablets
Trade Name: HEARTGARD-30;
Indications for use: For use in dogs to prevent canine
heartworm disease. HEARTGARD-30 (ivermectin) eliminates the
tissue stage of heartworm larvae (Dirofilaria immitis ).
Date of Approval: March 2, 1987
NADA 138-453 original approval
Sponsor: Southern Micro Blenders, Inc.
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 Corynebacterium pyogenes ). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: June 18, 1985
NADA 138-454 original approval
Sponsor: JR Specialty Supply 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 Corynebacterium pyogenes ). Feeds
containing Tylosin and Sulfamethazine must be withdrawn 15 days
before swine are slaughtered.
Date of Approval: December 10, 1985
NADA 138-455 original approval
Sponsor: Squire Laboratories, Inc.
Generic Name: 0.2% nitrofurazone dressing (water soluble)
Trade Name: Fura-Zone Solution, Brand of Nitrofurazone
Soluble Dressing
Indications for use: For use only on dogs, cats, and
horses (not intended for food use). For the prevention or treatment
of surface bacterial infections of wounds, burns, cutaneous
ulcers and abscesses after incision.
Date of Approval: February 18, 1987
NADA 138-456 original approval
Sponsor: A.L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate, monensin
sodium
Trade Name: BMD;, Coban;
Indications for use: For improved feed efficiency and
as an aid in the prevention of coccidiosis caused by Eimeria
necatrix, E. tenella, E. acervulina, E.
brunetti, E. maxima and E. mivati . Bacitracin
methylene disalicylate 4-50 grams per ton in combination with
110 grams per ton monensin.
Date of Approval: December 17, 1986
NADA 138-456 supplemental
approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate and monensin
sodium
Trade Name: BMD, Coban
Effect of Supplement:Monensin Sodium is presently approved
for use in broiler chicken feed at 90-110 per ton as an aid
in the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E. brunetti, E. mivati and E.
maxima (21 CFR 558.355(f)(1)(i)). Monensin Sodium is presently
approved for use in broiler chicken feed at 110 grams per ton
in combination with bacitracin methylene disalicylate at 4-50
grams per ton for improved feed efficiency and as an aid in
the prevention of coccidiosis caused by Eimeria necatrix,
E. tenella, E. acervulina, E. brunetti, E. mivati and E.
maxima (21 CFR 558-355(f)(1)(xxiv)). This supplemental NADA
provides data to support the request for Monensin Sodium to
be used at a range of 90-110 grams per ton in combination with
bacitracin methylene disalicylate at 4-50 grams per ton for
improved feed efficiency and as an aid in the prevention of
coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina,
E. brunetti, E. mivati and E. maxima.
Date of Approval: February 19,1992
NADA 138-612 original approval
Sponsor: Roussel-Uclaf
Generic Name: trenbolone acetate
Trade Name: Finaplix;
Indications for use: The product is an implanted anabolic
agent with slow release of trenbolone acetate which increases
rate of weight gain and improves feed efficiency in growing
finishing heifers and improves feed efficiency in growing finishing
steers.
Date of Approval: July 2, 1986
NADA 138-656 original approval
Sponsor: Farmland Industries, Inc.
Generic Name: pyrantel tartrate
Trade Name: BN Wormer-19.2 Banminth Premix
Indications For Use: 1. Continuous Feeding Program: For
aid in the prevention of migration and establishment of large
roundworm (Ascaris suum) infections; for aid in the prevention
of establishment of nodular worm (Oesophagostomum) infections
of swine. Feed continuously as the sole ration. 2. 3-Day Therapeutic
Program: For the removal and control of large roundworm (Ascaris
suum) infections of swine. Feed for three days as the sole
ration. 3. Single Therapeutic Program: For the removal and control
of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum)
infections of swine.
Date of Approval: October 4, 1985
NADA 138-657 original approval
Sponsor: VET LABS Limited, Inc.
Generic Name: nitrofurazone ointment
Trade Name: Nitrofurazone Ointment
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 19, 1987
NADA 138-703 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name:bacitracin zinc, roxarsone, and monensin
sodium
Trade Name: Albac;, 3-Nitro;, and Coban;
Indications for use: For improved feed efficiency and
as an aid in prevention of coccidiosis caused by Eimeria
necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima,
and E. mivati.
Date of Approval: September 15, 1986
NADA 138-792 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin sodium,
tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
Rumensin;, Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 6, 1990
NADA 138-792 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate, monensin sodium,
tylosin phosphate
Trade Name: MGA®, Rumensin®, and Tylan®
Effect of Supplement: These supplements provide for the
treatment of the approved combination of melengestrol acetate,
monensin and tylosin to be treated as a combination under the
provisions of the Animal Drug Availability Act of 1996, and
its reference to feed delivered drug combinations. The effect
is to provide for the addition of the coccidiosis claim for
monensin (0.14 to 0.42 mg/lb body weight depending on the severity
of the challenge, up to 360 mg/hd/day) and the addition of the
complete tylosin dose range (60 to 90 mg/hd/day) to this combination
with melengestrol acetate for heifers being fed in confinement
for slaughter.
Date of Approval: February 26, 2002
NADA 138-792 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA® 100/200 Premix, MGA® 500 Liquid
Premix, RUMENSIN®, 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 with tylosin or with tylosin and monensin.
Previous approvals have required a 48 hour pre-slaughter drug
withdrawal for heifers fed melengestrol acetate when fed in
combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994
NADA 138-828 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: virginiamycin, salinomycin
Trade Name: Stafac; lO,20,50, and 500 Type A Medicated
Article; Bio-Cox; Type A Medicated Article
Indications for use: Feed continuously as sole ration
to broiler chickens. For increased rate of weight gain, improved
feed efficiency and the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E.
brunetti and E. mivati : Stafac; (virginiamycin)
5g/ton ,Bio-Cox; (salinomycin) 40-60g/ton. For increased rate
of weight gain and the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti
and E. mivati :Stafac; (virginiamycin) 5-15g/ton, Bio-Cox;
(salinomycin) 40-60g/ton. This approval does not provide for
a single Type A Medicated Article containing both virginiamycin
and salinomycin.
Date of Approval: September 13, 1988
NADA 138-869 original approval
Sponsor: Med-Tech, Inc.
Generic Name: triamcinolone acetonide
Trade Name: Triamcinolone Acetonide Injection, 2 mg/ml
& 6 mg/ml
Indications For Use: Triamcinolone acetonide is a highly
potent glucocorticoid effective in the treatment of inflammation
and related disorders in dogs, cats and horses. It is also indicated
for use in the management and treatment of acute arthritis and
allergic and dermatologic disorders in dogs and cats.
Date of Approval: January 6, 1987
NADA 138-870original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin sodium,
tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
Rumensin;, Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 6, 1990
NADA 138-870 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate, monensin sodium,
tylosin phosphate
Trade Name: MGA®, Rumensin®, and Tylan®
Effect of Supplement: These supplements provide for the
treatment of the approved combination of melengestrol acetate,
monensin and tylosin to be treated as a combination under the
provisions of the Animal Drug Availability Act of 1996, and
its reference to feed delivered drug combinations. The effect
is to provide for the addition of the coccidiosis claim for
monensin (0.14 to 0.42 mg/lb body weight depending on the severity
of the challenge, up to 360 mg/hd/day) and the addition of the
complete tylosin dose range (60 to 90 mg/hd/day) to this combination
with melengestrol acetate for heifers being fed in confinement
for slaughter.
Date of Approval: February 26, 2002
NADA 138-870 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
RUMENSIN;, 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 with tylosin or with tylosin and monensin.
Previous approvals have required a 48 hour pre-slaughter drug
withdrawal for heifers fed melengestrol acetate when fed in
combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994
NADA 138-900 original approval
Sponsor: Richlyn Laboratories, Inc.
Generic Name: dichlorophene/toluene capsules
Trade Name: Dichlorophene/Toluene Capsules (Wormer for
Dogs and Cats)
Indications For Use: For removal of ascarids (Toxocara
canis and Toxascaris leonina) and hookworms (Ancylostoma
caninum and Uncinaria stenocephala) and as an aid
in removal of tapeworms (Taenia pisiformis, Dipylidium caninum,
and Echinococcus granulosus) from dogs and cats.
Date of Approval: October 22, 1987
NADA 138-902 original approval
Sponsor: Schering Animal Health
Generic Name: tioxidazole
Trade Name: Tiox Paste
Indications for use: Tiox (tioxidazole) Paste is indicated
for removal of mature large strongyles (Strongylus edentatus,
S.equinus , and S.vulgaris ), mature ascarids (Parascaris
equorum and immature (4th larval stage) pinworms (Oxyuris
equi ), and mature small strongyles (Triodontophorus
spp ).
Date of Approval: November 9, 1987
NADA 138-903
original approval
Sponsor: Syntex Agribusiness, Inc.
Generic Name: fenprostalene
Trade Name: Porcilene; (fenprostalene) sterile solution
Indications for use: Porcilene; (fenprostalene) sterile
solution is indicated for use in sows and gilts pregnant at
least 112 days for the induction of parturition.
Date of Approval: December 23, 1988
NADA 138-904 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid sodium,
tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
Bovatec;, Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 6, 1990
NADA 138-904 supplemental
approval
Sponsor: The Upjohn Company
Generic Names: melengestrol acetate, lasalocid, tylosin
Trade Names: 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. Previous approvals have required a 48 hour pre-slaughter
drug withdrawal for heifers fed melengestrol acetate when fed
in combination with these drugs.
Date of Approval: June 29, 1994
NADA 138-935 supplemental
approval
Sponsor: Pennfield Oil Company
Generic Name: chlortetracycline Type A medicated article
Trade Name: CHLORTETRACYCLINE, 50, 60, 70, 80, 100 &
100MR
Effect of Supplement: The effect of this Category II
supplement is to bring the drug product into compliance with
the National Academy of Science/National Research Council/ Drug
Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 138-935 supplemental approval
Sponsor: PennfField Oil Company
Generic Name: Chlortetracycline Pre-mix
Trade Name: Pennchlor Type A Medicated Article
Effect of Supplement: Changes the withdrawal time from
10 days to one day withdrawal period for cattle
Date of Approval: March 24 1999
NADA 138-938 original approval
Sponsor: Pennfield Oil Company
Generic Name:oxytetracycline pre-mix
Trade Name: Oxytetracycline 50, 100 & 100MR
Indications for use: For the control and treatment of
specific diseases susceptible to oxytetracycline pre-mix in
swine, calves, cattle, chickens, turkeys, sheep, and honey bees.
Date of Approval: March 15, 1996
NADA 138-941 original approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride/pyrantel tartrate
Trade Name: Lincomix;/Banminth;
Indications for use: For reduction in the severity of
swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae
; aid in the prevention of migration and establishment of
large roundworm ( Ascaris suum ) infections; aid in the
prevention of establishment of nodular worm (Oesophaqostomum
spp ) infections of swine when fed in accordance with directions
for use.
Date of Approval: December 11, 1985
NADA 138-952 original approval
Sponsor: Elanco Products Company
Generic Name: narasin and nicarbazin
Trade Name: MAXIBAN;
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by E. necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima .
Date of Approval: January 18, 1989
NADA 138-953 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: virginiamycin, salinomycin, roxarsone
Trade Name: Stafac; 500 Type A Medicated Article, Stafac;
50 Type A Medicated Article, Stafac; 20 Type A Medicated Article,
Stafac; lO Type A Medicated Article, Bio-Cox;Type A Medicated
Article, 3-Nitro;-10, 3-Nitro;-20, 3-Nitro;-50 , 3-Nitro;-80
Type A Medicated Articles
Indications for use: Feed continuously as sole ration
to broiler chickens. For improved feed efficiency, for the prevention
of coccidiosis caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunetti and E. mivati , including
some field strains of E. tenella which are more susceptible
to roxarsone combined with salinomycin than to salinomycin alone.This
approval does not provide for a single Type A Medicated Article
containing virginiamycin, salinomycin and roxarsone.
Date of Approval: November 1, 1988
NADA 138-954 original approval
Sponsor: Pitman-Moore, Inc.
Generic Name: mebendazole and trichlorfon
Trade Name: TELMIN(TM) B Paste Equine Wormer
Indications for use: TELMIN B Paste is indicated in the
treatment of infections caused by bots (Gastrophilus intestinalis
and G. nasalis ), large roundworms (Parascaris equorum
), large strongyles (Strongylus edentatus, S. equinus,
S. vulgaris ), small strongyles and pinworms (Oxyuris
equi ).
Date of Approval: April 18, 1986
NADA 138-955 original approval
Sponsor: Medico Industries, Inc.
Generic Name: tylosin Injection
Trade Name: Tylosin Injection, 50 mg/ml & 200 mg/ml
Indications for use: BOVINE: indicated for use in the
treatment of respiratory complex (shipping fever, pneumonia)
usually associated with Pasteurella multocida and Corynebacterium
pyogenes ; foot rot (necrotic pododermatitis) and calf diphtheria
caused by Fusobacterium necrophorum and metritis caused
by Corynebacterium pyogenes in beef cattle and nonlactating
dairy cattle. SWINE: indicated for use in the treatment of arthritis
caused by Mycoplasma hyosynoviae ; swine pneumonia caused
by Pasteurella spp.; swine erysipelas caused by Erysipelothrix
rhusiopathiae ; acute swine dysentery associated with Treponema
hyodysenteriae when followed by appropriate medication in
the drinking water and/or feed.
Date of Approval: December 10, 1985
NADA 138-992 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid sodium,
tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
Bovatec;, Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 6, 1990
ANADA 138-992 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; Premixes
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 138-993 original approval
Sponsor: Moorman Mfg. Company
Generic Name: lasalocid
Trade Name: MoorMan's Cattle Minerals BT Medicated
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: May 13, 1987
NADA 138-995 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and tylosin phosphate
Trade Name: MGA ; - 100/200 Premix and MGA; - 500 Liquid
Premix and Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 8, 1990
NADA 138-995 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix,
RUMENSIN;, 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 with tylosin or with tylosin and monensin.
Previous approvals have required a 48 hour pre-slaughter drug
withdrawal for heifers fed melengestrol acetate when fed in
combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994
NADA 139-075
original approval
Sponsor: American Cyanamid Company
Generic Name: maduramicin ammonium
Trade Name: CYGRO; 1% Type A Medicated Article
Indications for use: For use in the manufacture of broiler
chicken feeds. For the prevention of coccidiosis in broiler
chickens caused by Eimeria acervulina, E. tenella, E. brunetti,
E. maxima, E. necatrix and E. mivati.
Date of Approval: February 2, 1989
NADA 139-189 supplemental
approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD;
Effect of Supplement: The original approval provided
for a 25 lb. medicated molasses block containing 750 milligrams
of fenbendazole per pound as a beef cattle anthelmintic. The
molasses block requires an 11-day withdrawal. This supplemental
approval provides for a 33-1/2 pound cold press medicated 20%
protein feedblock containing 750 milligrams of fenbendazole
per pound as a beef cattle anthelmintic. The cold press 20%
protein block requires a 16-day withdrawal period.
Date of Approval: May 15, 1989
NADA 139-190 original approval
Sponsor: International Minerals & Chemical Corporation
Generic Name: bacitracin zinc - salinomycin sodium -
roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Baciferm; - Bio-Cox; - 3-Nitro;
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;
for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 5, 1986
NADA 139-191 original approval
Sponsor: Purina Mills, Inc.
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Chewable Tablets
Indications for Use: For removal of ascarids (Toxocara
canis; Toxascaris leonina) and hookworms (Ancylostoma
caninum; Uncinaria stenocephala) in dogs and puppies. To
prevent reinfection of Toxocara canis in puppies and
adult dogs and in lactating bitches after whelping.
Date of Approval: October 13, 1987
NADA 139-192 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and tylosin phosphate
Trade Name: MGA ; - 100/200 Premix and MGA; - 500 Liquid
Premix and Tylan;
Indications for use: For increased rate of weight gain,
improved feed efficiency, suppression of estrus (heat), and
reduced incidence of liver abscesses in heifers fed in confinement
for slaughter.
Date of Approval: August 8, 1990
NADA 139-192 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA;100/200 Premix, MGA;500 Liquid Premix,
RUMENSIN;, 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 with tylosin or with tylosin and monensin.
Previous approvals have required a 48 hour pre-slaughter drug
withdrawal for heifers fed melengestrol acetate when fed in
combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994
NADA 139-235 original approval
Sponsor: International Minerals & Chemical Corporation
Generic Name: bacitracin zinc - salinomycin sodium
Trade Name: Baciferm; - Bio-Cox;
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;
for increased rate of weight gain.
Date of Approval: May 19, 1986
NADA 139-236 supplemental
approval
Sponsor: VET-A-MIX, Inc.
Generic Name: xylazine injectable solution, 20 mg/ml
Trade Name: AnaSed(TM), Injectable Solution
Effect of Supplement: Supplement provides for use of
the product in an additional species (dog).
Date of Approval: April 24, 1990
NADA 139-236 supplemental
approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine hydrochloride
Trade Name: AnaSed; Injectable, 20 mg/mL
Effect
of Supplement:This supplement provides for modification
of the labeling to include use of AnaSed® 20 mg/mL in cats.
Date of Approval: May 16, 1995
NADA 139-236 supplemental
approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine 100 mg/mL
Trade Name: AnaSed; Injectable
Effect of Supplement:This supplement provides for modification
of the labeling to include use of AnaSed; 100 mg/mL in Fallow
Deer, Mule Deer, Sika Deer, White-tailed Deer, and Elk.
Date of Approval: May 16, 1995
NADA 139-236 supplemental
approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine 100 mg/mL
Trade Name: AnaSed; Injectable
Effect of Supplement: This supplement provides for a
300 mg/mL xylazine concentration, in addition to the approved
concentration of 100 mg/mL for Cervidae.
Date of Approval: February 10, 2003
NADA 139-237 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: gonadorelin hydrochloride
Trade Name: Factrel;
Indications for use: Factrel; is indicated for the treatment
of ovarian follicular cysts in cattle. The treatment effect
of Factrel; when used in cattle with ovarian cysts is a reduction
in the number of days to first estrus.
Date of Approval: November 11, 1989
NADA 139-239 original approval
Sponsor: Growmark, Inc.
Generic Name: pyrantel tartrate
Trade Name: SWINE-GUARD-BN Banminth Premixes
Indications for Use:
CONTINUOUS FEEDING PROGRAM: For aid in the prevention of migration
and establishment of large roundworm (Ascaris suum) infections;
for aid in the prevention of establishment of nodular worm (Oesophagostomum)
infections of swine. Feed continuously as the sole ration. 3-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 (Oesophagostomum) infections of swine. Withdraw
this feed 24 hours prior to slaughter.
Date of Approval: November 18, 1995
NADA 139-301 original approval
Sponsor: Walnut Grove Products
Generic Name: tylosin (as tylosin phosphate) combined
with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premix
Indications for use: For maintaining weight gains and
feed efficiency in the presence of atrophic rhinitis; lowering
the incidence and severity of Borderella bronchiseptica
rhinitis; prevention of swine dysentery (vibrionic); control
of swine pneumonias 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: November 22, 1985
NADA
139-472 original approval
Sponsor: Fermenta Animal Health Co.
Generic Name: tiamulin
Trade Name: DENAGARD Antibiotic Premix (Type A Medicated
Article) DENAGARD 5 Medicated Premix (Type A Medicated Article)
DENAGARD 10 Medicated Premix (Type A Medicated Article)
Indications for use: For the control of swine dysentery
associated with Treponema hyodysenteriaesusceptible to
tiamulin. For increased rate of weight gain from weaning to
125 pounds body weight.
Date of Approval: July 17, 1987
NADA 139-472
supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate
Trade Name: DENAGARD; Antibiotic Premix, DENAGARD; 5
Medicated Premix, DENAGARD; 10 Medicated Premix (Type A Medicated
Articles)
Effect of Supplement: To add the label claim for treatment
of swine dysentery at 200 g/ton for 14 days.
Date of Approval: July 7, 1994
NADA 139-472 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: tiamulin hydrogen fumarate
Trade Name: Denagard® (Tiamulin) Medicated Premix
Effect of Supplement: This supplemental application amends
the approved NADA to provide for the use of DENAGARD® (Tiamulin)
Type A Medicated Article "for control of porcine proliferative
enteropathies (ileitis) associated with Lawsonia intracellularis."
Date of Approval: November 26, 2001
NADA 139-473 original approval
Sponsor: American Hoechst Corporation
Generic Name:virginiamycin; halofuginone hydrobromide
Trade Name: Stafac, Stenorol ;
Indications for use: For the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima,
E. mivati, E. brunetti; For increased rate of wweight gain;
For improved feed efficiency in broiler chickens.
Date of Approval: April 22, 1986
NADA 139-488 original approval
Sponsor: Stutts Scientific Service, Inc.
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: June 23, 1986
NADA 139-600 original approval
Sponsor: Arkansas Micro Specialties, Inc.
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 treatment and control
of swine dysentery (vibrionic) following initial medication
of Tylan Plus Vitamins in drinking water. 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. Feeds containing tylosin at 800 to 1000 grams
per ton must be withdrawn five days before chickens are slaughtered.
Date of Approval: February 19, 1986
NADA 139-601 original approval
Sponsor: Arkansas Micro Specialties, Inc.
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 bronchiseptical 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: February 19, 1986
NADA 139-633 original approval
Sponsor: Wildlife Laboratories, Incorporated
Generic Name: carfentanil citrate
Trade Name: WILDNIL
Indications for use: For use as an immobilizing agent
in free-ranging or confined members of the family Cervidae (deer,
elk, moose).
Date of Approval: September 26, 1988
NADA 139-858 original approval
Sponsor: American Cyanamid Company
Generic Name: levamisole resinate and famphur
Trade Name: TRAMISOL; X-TRA
Indications for use: For treatment of cattle infected
with the following parasites: STOMACH WORMS: Haemonchus,
Trichostrongylus, Ostertagia ; INTESTINAL WORMS: Trichostrongylus,
Cooperia, Nematodirus, Bunostomum, Oesophagostomum ; LUNGWORMS:
Dictyocaulus ; BITING LICE: Bovicola ; SUCKING
LICE: Linognathus, Solenoptes . It is not effective against
lice eggs.
Date of Approval: June 16, 1988
NADA 139-876 original approval
Sponsor: The Upjohn Company, Agricultural Division
Generic Name:melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Indications for use: For increased rate of weight gain,
improved feed efficiency and suppression of estrus (heat) in
heifers fed in confinement for slaughter.
Date of Approval: September 8, 1987
NADA 139-876 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. Previous approvals have required a 48 hour pre-slaughter
drug withdrawal for heifers fed melengestrol acetate when fed
in combination with these drugs.
Date of Approval: June 29, 1994
NADA 139-877 original approval
Sponsor: Pitman-Moore, Inc.
Generic Name: levamisole
Trade Name: Totalon Topical Cattle Anthelmintic
Indications for use: Broad spectrum anthelmintic effective
against certain stomach worm, intestinal worm, and lung worm
nematode infections in cattle.
Date of Approval: April 6, 1987
NADA 139-879 original approval
Sponsor: Wildlife Laboratories
Generic Name: carnidazole
Trade Name: Spartrix
Indications for use: Spartrix (Carnidazole) is indicated
for oral treatment of trichomoniasis (canker) in ornamental
and homing (non-food) pigeons.
Date of Approval: July 31, 1989
NADA 139-913 original approval
Sponsor: Solvay Veterinary, Inc.
Generic Name: hyaluronate sodium
Trade Name: Equron
Indications for use: Equron is indicated for the treatment
of joint dysfunction in horses due to noninfectious synovitis
associated with equine osteoarthritis.
Date of Approval: July 10, 1986
Web page updated by swd,
November 16, 2004,4:38 PM ET
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