Drug Approvals for December 1997

Definitions and Notes

December 1997

Original New Drug Applications

Original Application #: 020899
Approval Date: 31-DEC-97
Trade Name: OPTISON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: MOLECULAR BIOSYSTEMS, INC.
Active Ingredient(s): HUMAN ALBUMIN MICROSPHERES
OTC/RX Status: RX
Indication(s): For the use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders

Original Application #: 020706
Approval Date: 29-DEC-97
Trade Name: EMADINE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES, INC.
Active Ingredient(s): EMEDASTINE DIFUMARATE
OTC/RX Status: RX
Indication(s): For the temporary relief of the signs and symptoms of allergic conjunctivitis

Original Application #: 020786
Approval Date: 24-DEC-97
Trade Name: ALLEGRA-D
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: HOECHST MARION ROUSSEL, INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older

Original Application #: 020607
Approval Date: 24-DEC-97
Trade Name: ARTHROTEC
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL
OTC/RX Status: RX
Indication(s): Treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk for developing NSAID-induced gastric and duodenal ulcers and their complications

Original Application #: 020587
Approval Date: 24-DEC-97
Trade Name: SCLEROSOL INTRAPLEURAL AEROSOL
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: POWDER
Applicant: BRYAN CORPORATION
Active Ingredient(s): STERILE TALC POWDER
OTC/RX Status: RX
Indication(s): For the prevention of the recurrence of malignant pleural effusions in symptomatic patients

Original Application #: 020813
Approval Date: 23-DEC-97
Trade Name: KLONOPIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: WAFER
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Indication(s): Seizure disorders; Panic disorder

Original Application #: 050753
Approval Date: 22-DEC-97
Trade Name: TOBI
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: PATHOGENESIS CORP
Active Ingredient(s): TOBRAMYCIN
OTC/RX Status: RX
Indication(s): For the management of cystic fibrosis patients with Pseudomonas aeruginosa

Original Application #: 020741
Approval Date: 22-DEC-97
Trade Name: PRANDIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): REPAGLINIDE
OTC/RX Status: RX
Indication(s): As an adjunct to diet and exercise to lower blood glucose in patients with non-insulin dependent (type II) diabetes mellitus whose hyperglycemia cannot be controlled satisfactorily with diet and exercise alone; for use in combination with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either repaglinide or metformin alone

Original Application #: 020738
Approval Date: 22-DEC-97
Trade Name: TEVETEN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): EPROSARTAN MESYLATE
OTC/RX Status: RX
Indication(s): For use in the management of essential hypertension

Original Application #: 020788
Approval Date: 19-DEC-97
Trade Name: PROPECIA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX
Indication(s): Treatment of male pattern hair loss (androgenetic alopecia) in men only

Original Application #: 020686
Approval Date: 19-DEC-97
Trade Name: LUMENHANCE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: BRACCO DIAGNOSTICS INC
Active Ingredient(s): MANGANESE CHLORIDE TETRAHYDRATE
OTC/RX Status: RX
Indication(s): As a magnetic resonance imaging (MRI) contrast media

Original Application #: 020791
Approval Date: 18-DEC-97
Trade Name: TESTODERM TTS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: FILM, EXTENDED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Indication(s): For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, primary hypogonadism or hypogonadotropic hypogonadism

Original Application #: 020760
Approval Date: 18-DEC-97
Trade Name: TROVAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): ALATROFLOXACIN MESYLATE
OTC/RX Status: RX
Indication(s): Broad-spectrum antibacterial agent indicated for the treatment of infections caused by susceptible strains of microorganisms

Original Application #: 020759
Approval Date: 18-DEC-97
Trade Name: TROVAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): TROVAFLOXACIN MESYLATE
OTC/RX Status: RX
Indication(s): Broad-spectrum antibacterial agent indicated for the treatment of infections caused by susceptible strains of microorganisms

Original Application #: 020799
Approval Date: 16-DEC-97
Trade Name: FLOXIN OTIC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: DAIICHI PHARMACEUTICAL CO LTD
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX
Indication(s): Treatment of otitis externa, chronic suppurative otitis media, and acute otitis media in patients with tympanostomy tubes

Original Application #: 050746
Approval Date: 11-DEC-97
Trade Name: BACTROBAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): MUPIROCIN CALCIUM
OTC/RX Status: RX
Indication(s): Treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes

Original Application #: 020742
Approval Date: 10-DEC-97
Trade Name: BSS
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
OTC/RX Status: RX
Indication(s): For use as an extraocular and intraocular irrigating solution during ocular surgical procedures involving perfusion of the eye with an expected maximum duration of less than 60 minutes

Original Application #: 020675
Approval Date: 10-DEC-97
Trade Name: URSO
Chemical Type: 5
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: AXCAN PHARMA US INC
Active Ingredient(s): URSODIOL
OTC/RX Status: RX
Indication(s): For the treatment of primary biliary cirrhosis

Original Application #: 020815
Approval Date: 09-DEC-97
Trade Name: EVISTA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): RALOXIFENE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the prevention of osteoporosis in postmenopausal women

Original Application #: 020148
Approval Date: 08-DEC-97
Trade Name: MIGRANAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SPRAY, METERED
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX
Indication(s): For the acute treatment of migraine headaches with or without aura

Original Application #: 020696
Approval Date: 04-DEC-97
Trade Name: ANTIZOL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ORPHAN MEDICAL INC
Active Ingredient(s): FOMEPIZOLE
OTC/RX Status: RX
Indication(s): Antidote to ethylene glycol (antifreeze) poisoning in patients who have ingested, or are suspected of having ingested ethylene glycol

Efficacy Supplemental New Drug Applications

Application #:050585 Efficacy Supplement#: 046
Type: SE2 to Original New Drug Application
Approval Date: 23-DEC-97
Trade Name: ROCEPHIN
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CEFTRIAXONE SODIUM
OTC/RX Status: RX
Efficacy Claim: Single dose therapy in the treatment of acute otitis media

Application #:019151Efficacy Supplement#:002
Type: SE1 to Original New Drug Application
Approval Date: 23-DEC-97
Trade Name: RYTHMOL
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): PROPAFENONE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the new indication of paroxysmal supraventricular tachycardia (PSVT)

Application #:050688 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 22-DEC-97
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Efficacy Claim: For acute exacerbations of chronic bronchitis caused by S. Pneumoniae, H. Influenzae (including beta-lactamase-producing strains), H. Parainfluenzae, or M. catarrhalis

Application #: 050687 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 22-DEC-97
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Efficacy Claim: For acute exacerbations of chronic bronchitis caused by S. Pneumoniae, H. Influenzae (including beta-lactamase-producing strains), H. Parainfluenzae, or M. catarrhalis

Application #: 050678 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 19-DEC-97
Trade Name: DYNABAC
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): DIRITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: For the 5-day use for the treatment of patients with acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and for the treatment of patients with uncomplicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible strains) or Streptococcus pyogenes. Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis

Application #: 020522 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 17-DEC-97
Trade Name: NUTROPIN AQ
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: For the replacement of endogenous growth hormone in adult patients with growth hormone deficiency

Application #: 011559 Efficacy Supplement#: 030
Type: SE5 to Original New Drug Application
Approval Date: 17-DEC-97
Trade Name: BREVITAL SODIUM
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): METHOHEXITAL SODIUM
OTC/RX Status: RX
Efficacy Claim: Provides for a cautionary statement advising against the intravenous use of Brevital in pediatric patients from any age category

Application #: 019676 Efficacy Supplement#: 009
Type: SE1 to Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: For the replacement of endogenous growth hormone in patients with growth hormone deficiency

Application #: 020498 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CASODEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): BICALUTAMIDE
OTC/RX Status: RX
Efficacy Claim: For use in combination therapy with an LHRH analogue in the treatment of advanced prostate cancer

Application #: 020460 Efficacy Supplement#: 008
Type: SE2 to Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CYTOVENE
Dosage Form: CAPSULE
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): GANCICLOVIR
OTC/RX Status: RX
Efficacy Claim: Provides for a 500mg strength

Application #: 050590 Efficacy Supplement#: 030
Type: SE5 to Original New Drug Application
Approval Date: 11-DEC-97
Trade Name: TIMENTIN
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients

Approvable Original New Drug Applications

Original Application #: 020717
Approvable Date: 29-DEC-97
Trade Name: PROVIGIL
Dosage Form: TABLET
Applicant: CEPHALON INC
Active Ingredient(s): MODAFINIL
OTC/RX Status: RX

Original Application #: 020369
Approvable Date: 23-DEC-97
Trade Name: CILOXAN
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020801
Approvable Date: 19-DEC-97
Trade Name: PEPCID AC
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Application #: 020816
Approvable Date: 04-DEC-97
Trade Name: AZOPT
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
ActiveIngredient(s): BRIMZOLAMIDE
OTC/RX Status: RX

Original Application #: 020764
Approvable Date: 03-DEC-97
Trade Name: LAMICTAL CD
Dosage Form: TABLET, CHEWABLE, DISPERSIBLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX

Original Application #: 020795
Approvable Date: 02-DEC-97
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074964
Approval Date: 30-DEC-97
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 074898
Approval Date: 30-DEC-97
Trade Name: IOPAMIDOL-200 (-250; -300; -370)
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074636
Approval Date: 30-DEC-97
Trade Name: IOPAMIDOL-200 (-250; -300; -370)
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074991
Approval Date: 29-DEC-97
Trade Name: LOPERAMIDE HCL
Dosage Form: SOLUTION
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074896
Approval Date: 29-DEC-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 074832
Approval Date: 29-DEC-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 074827
Approval Date: 29-DEC-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 074788
Approval Date: 29-DEC-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 074650
Approval Date: 29-DEC-97
Trade Name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage Form: SUSPENSION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX

Original Abbreviated Application # 040212
Approval Date: 29-DEC-97
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 074844
Approval Date: 23-DEC-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074591
Approval Date: 22-DEC-97
Trade Name: GLYBURIDE
Dosage Form: TABLET
Applicant: MOVA PHARMACEUTICALS CORP
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Original Abbreviated Application # 074893
Approval Date: 19-DEC-97
Trade Name: HALOPERIDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Original Abbreviated Application # 074885
Approval Date: 19-DEC-97
Trade Name: ACYCLOVIR
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074601
Approval Date: 19-DEC-97
Trade Name: DIPYRIDAMOLE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX

Original Abbreviated Application # 074538
Approval Date: 18-DEC-97
Trade Name: TRIVORA-21; TRIVORA-28
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX

Original Abbreviated Application # 074884
Approval Date: 17-DEC-97
Trade Name: CLEMASTINE FUMARATE
Dosage Form: SYRUP
Applicant: SILARX PHARMACEUTICALS INC
Active Ingredient(s): CLEMASTINE FUMARATE

Original Abbreviated Application # 074879
Approval Date: 10-DEC-97
Trade Name: KETOPROFEN
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): KETOPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 074712
Approval Date: 10-DEC-97
Trade Name: LACTULOSE
Dosage Form: SOLUTION
Applicant: INALCO SPA
Active Ingredient(s): LACTULOSE
OTC/RX Status: RX

Original Abbreviated Application # 040252
Approval Date: 10-DEC-97
Trade Name: CARISOPRODOL AND ASPIRIN
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): ASPIRIN; CARISOPRODOL
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval

None

Labeling Supplements to Original New Drug Applications

Application #: 018874 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 31-DEC-97
Trade Name: CALCIJEX
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES INC
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX

Application #: 010375 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 30-DEC-97
Trade Name: MEDIHALER-ISO
Dosage Form: SPRAY, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): ISOPROTERENOL SULFATE
OTC/RX Status: RX

Application #: 020689 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 23-DEC-97
Trade Name: POSICOR
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MIBEFRADIL DIHYDROCHLORIDE
OTC/RX Status: RX

Application #: 020478 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 23-DEC-97
Trade Name: ULTANE
Dosage Form: LIQUID
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SEVOFLURANE
OTC/RX Status: RX

Application #:020180 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 19-DEC-97
Trade Name: PROSCAR
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 020225 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 17-DEC-97
Trade Name: IMDUR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING CORP
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Application #: 020358 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 16-DEC-97
Trade Name: WELLBUTRIN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020358 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 16-DEC-97
Trade Name: WELLBUTRIN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #:020720Labeling Supplement#:007
To Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 15-DEC-97
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 050639 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CLEOCIN PHOSPHATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Application #: 050441 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CLEOCIN PHOSPHATE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Application #: 050162 Labeling Supplement#: 080
To Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CLEOCIN HCL
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017703 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CYLERT
Dosage Form: TABLET, CHEWABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Application #: 016832 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 12-DEC-97
Trade Name: CYLERT
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Application #: 020377 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: CORDARONE
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020059 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: ADENOSCAN
Dosage Form: INJECTABLE
Applicant: MEDCO RESEARCH INC
Active Ingredient(s): ADENOSINE
OTC/RX Status: RX

Application #: 019797 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: NULYTELY
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 019797 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: NULYTELY
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 019287 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: DIZAC
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Application #: 019081 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: ESTRADERM
Dosage Form: FILM, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 018153 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 10-DEC-97
Trade Name: BECLOVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 012436 Labeling Supplement#: 071
To Original New Drug Application
Approval Date: 05-DEC-97
Trade Name: DIMETAPP
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): BROMPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 016618 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 02-DEC-97
Trade Name: PONDIMIN
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): FENFLURAMINE HYDROCHLORIDE
OTC/RX Status: RX