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Drug Approvals for March 1998
Definitions and Notes
March 1998
Original New Drug Applications
Original Application #: 020827
Approval Date: 30-MAR-98
Trade Name: MONISTAT 3
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: ADVANCED CARE PRODUCTS
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC
Indication(s): For the over-the-counter treatment of vulvovaginal candidiasis
Original Application #: 020369
Approval Date: 30-MAR-98
Trade Name: CILOXAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of bacterial conjunctivitis caused by susceptible strains of designated microorganisms
Original Application #: 020895
Approval Date: 27-MAR-98
Trade Name: VIAGRA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: PFIZER CHEMICAL CORP
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX
Indication(s): Treatment of erectile dysfunction
Original Application #: 020771
Approval Date: 25-MAR-98
Trade Name: DETROL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLTERODINE TARTRATE
OTC/RX Status: RX
Indication(s): Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Original Application #: 020841
Approval Date: 09-MAR-98
Trade Name: LOTEMAX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: BAUSCH AND LOMB
Active Ingredient(s): LOTEPREDNOL ETABONATE
OTC/RX Status: RX
Indication(s): For the treatment of post-operative inflammation following ocular surgery
Original Application #: 020803
Approval Date: 09-MAR-98
Trade Name: ALREX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: BAUSCH AND LOMB
Active Ingredient(s): LOTEPREDNOL ETABONATE
OTC/RX Status: RX
Indication(s): For the temporary relief of signs and symptoms of seasonal allergic conjunctivitis
Original Application #: 020583
Approval Date: 09-MAR-98
Trade Name: LOTEMAX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: BAUSCH AND LOMB
Active Ingredient(s): LOTEPREDNOL ETABONATE
OTC/RX Status: RX
Indication(s): For the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye
Original Application #: 020807
Approval Date: 06-MAR-98
Trade Name: REFLUDAN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL
Active Ingredient(s): LEPIRUDIN
OTC/RX Status: RX
Indication(s): For anticoagulation in patients with heparin-induced thrombocytopenia (HIT) and thromboembolic disease in order to prevent further thromboembolic complications
Original Application #: 020818
Approval Date: 06-MAR-98
Trade Name: DIOVAN HCT
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): HYDROCHLOROTHIAZIDE; VALSARTAN
OTC/RX Status: RX
Indication(s): Treatment of hypertension
Efficacy Supplemental New Drug Applications
Application #: 020164 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 27-MAR-98
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the prevention of ischemic complications of unstable angina and non-Q-wave mycoardial infarction, when concurrently administered with aspirin
Application #: 019955 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 25-MAR-98
Trade Name: DDAVP
Dosage Form: TABLET
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): DESMOPRESSIN ACETATE
OTC/RX Status: RX
Efficacy Claim: New indication for primary nocturnal enuresis
Application #: 020559 Efficacy Supplement #: 002
Type: SE2 to Original New Drug Application
Approval Date: 23-MAR-98
Trade Name: TRITEC
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE BISMUTH CITRATE
OTC/RX Status: RX
Efficacy Claim: Provides for a change in the Dosage and Administration section of the Tritec labeling to allow for a reduction in the dosing frequency of clarithromycin when used for the approved indication
Application #: 020180 Efficacy Supplement #: 016
Type: SE1 to Original New Drug Application
Approval Date: 20-MAR-98
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
Efficacy Claim: Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery
Application #: 020180 Efficacy Supplement #: 015
Type: SE1 to Original New Drug Application
Approval Date: 20-MAR-98
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
Efficacy Claim: Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery
Application #: 020406 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 12-MAR-98
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim: New indication for short-term treatment of symptomatic gastroesophageal reflux disease (GERD)
Application #: 019898 Efficacy Supplement #: 020
Type: SE1 to Original New Drug Application
Approval Date: 11-MAR-98
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: Provides for the reduction of triglycerides as a new indication
Application #: 050680 Efficacy Supplement#: 002
Type: SE2 to Original New Drug Application
Approval Date: 02-MAR-98
Trade Name: CLEOCIN
Dosage Form: CREAM
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Efficacy Claim: Provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosis
Approvable Original New Drug Applications
Original Application #: 020836
Approvable Date: 05-MAR-98
Trade Name: AZMACORT HFA
Dosage Form: AEROSOL, METERED
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Original Abbreviated Application # 074995
Approval Date: 31-MAR-98
Trade Name: DOBUTAMINE HCL
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075187
Approval Date: 30-MAR-98
Trade Name: DIFLORASONE DIACETATE
Dosage Form: CREAM
Applicant: ALTANA INC
Active Ingredient(s): DIFLORASONE DIACETATE
OTC/RX Status: RX
Original Abbreviated Application # 074823
Approval Date: 30-MAR-98
Trade Name: TERAZOSIN HCL
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075082
Approval Date: 25-MAR-98
Trade Name: METHADONE HCL
Dosage Form: TABLET, DISPERSIBLE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): METHADONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074978
Approval Date: 25-MAR-98
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX
Original Abbreviated Application # 074909
Approval Date: 25-MAR-98
Trade Name: ALPRAZOLAM
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): ALPRAZOLAM
OTC/RX Status: RX
Original Abbreviated Application # 074928
Approval Date: 19-MAR-98
Trade Name: NICARDIPINE HCL
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074471
Approval Date: 19-MAR-98
Trade Name: NALBUPHINE HCL
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): NALBUPHINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075124
Approval Date: 18-MAR-98
Trade Name: DILTIAZEM HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075021
Approval Date: 18-MAR-98
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 064170
Approval Date: 18-MAR-98
Trade Name: CEFAZOLIN SODIUM
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 074863
Approval Date: 13-MAR-98
Trade Name: CLEMASTINE FUMARATE
Dosage Form: SYRUP
Applicant: MORTON GROVE ACQUISITION CORP
Active Ingredient(s): CLEMASTINE FUMARATE
OTC/RX Status: RX
Original Abbreviated Application # 040182
Approval Date: 13-MAR-98
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: ELIXIR
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX
Original Abbreviated Application # 075074
Approval Date: 11-MAR-98
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 040235
Approval Date: 11-MAR-98
Trade Name: PHENTOLAMINE MESYLATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): PHENTOLAMINE MESYLATE
OTC/RX Status: RX 03/19/98 09-mar-98 - 19-mar-98
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
None
Labeling Supplements to Original New Drug Applications
Application #: 011839 Labeling Supplement #: 067
To Original New Drug Application
Approval Date: 31-MAR-98
Trade Name: PROVERA
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX
Application #: 020700 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 30-MAR-98
Trade Name: MUSE
Dosage Form: SUPPOSITORY
Applicant: VIVUS INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Application #: 020641 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 30-MAR-98
Trade Name: CLARITIN
Dosage Form: SYRUP
Applicant: SCHERING CORP
Active Ingredient(s): LORATADINE
OTC/RX Status: RX
Application #: 019615 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 27-MAR-98
Trade Name: DOPAMINE HCL IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020379 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 26-MAR-98
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Application #: 018920 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 25-MAR-98
Trade Name: M.V.I. PEDIATRIC
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
OTC/RX Status: RX
Application #: 050672 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 24-MAR-98
Trade Name: CEFTIN
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Application #: 050605 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 24-MAR-98
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Application #: 020571 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 18-MAR-98
Trade Name: CAMPTOSAR
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): IRINOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020489 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 18-MAR-98
Trade Name: ANDRODERM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: THERATECH INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Application #: 020330 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 18-MAR-98
Trade Name: TIMOPTIC-XE
Dosage Form: SOLUTION, GEL FORMING/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Application #: 019463 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 18-MAR-98
Trade Name: TIMOPTIC IN OCUDOSE
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Application #: 018086 Labeling Supplement #: 052
To Original New Drug Application
Approval Date: 18-MAR-98
Trade Name: TIMOPTIC
Dosage Form: SOLUTION/ DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Application #: 019339 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 16-MAR-98
Trade Name: HEPARIN SODIUM IN 5% DEXTROSE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX
Application #: 020586 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 13-MAR-98
Trade Name: MERETEK UBT KIT (W/ PRANACTIN)
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: MERETEK
Active Ingredient(s): UREA C-13
OTC/RX Status: RX
Application #: 020101 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 13-MAR-98
Trade Name: PROZAC
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019030 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 13-MAR-98
Trade Name: BRETYLIUM TOSYLATE
Dosage Form: INJECTABLE IN PLASTIC CONTAINER
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): BRETYLIUM TOSYLATE
OTC/RX Status: RX
Application #: 018936 Labeling Supplement #: 051
To Original New Drug Application
Approval Date: 13-MAR-98
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019002 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 10-MAR-98
Trade Name: VASCOR
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): BEPRIDIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020071 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 05-MAR-98
Trade Name: DESOGEN
Dosage Form: TABLET
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 020518 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 04-MAR-98
Trade Name: RETROVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX
Application #: 020199 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 04-MAR-98
Trade Name: HIVID
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ZALCITABINE
OTC/RX Status: RX
Application #: 019951 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 04-MAR-98
Trade Name: RETROVIR
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX
Application #: 019910 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 04-MAR-98
Trade Name: RETROVIR
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX
Application #: 019655 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 04-MAR-98
Trade Name: RETROVIR
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX
Application #: 020668 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 03-MAR-98
Trade Name: LEXXEL
Dosage Form: TABLET
Applicant: ASTRA MERCK INC
Active Ingredient(s): ENALAPRIL MALEATE; FELODIPINE
OTC/RX Status: RX
Application #: 019758 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 03-MAR-98
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX
Application #: 018731 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 02-MAR-98
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
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Date created: May 4, 1998; last updated: June 20, 2005 |
