Drug Approvals for August 1997

Definitions and Notes

August 1997

Original New Drug Applications

Original Application #: 020808
Approval Date: 29-AUG-97
Trade Name: VISIPAQUE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): IODIXANOL
OTC/RX Status: RX
Indication(s): Intra-arterial - for visceral intra-arterial digital subtraction angiography; for angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, cerebral arteriography: Intravenous - for CECT imaging of the head and body, excretory urography, and peripheral venography

Original Application #: 020626
Approval Date: 26-AUG-97
Trade Name: IMITREX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SPRAY
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN
OTC/RX Status: RX
Indication(s): Treatment of migraine headaches

Original Application #: 050740
Approval Date: 11-AUG-97
Trade Name: AMBISOME
Chemical Type: 2
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): AMPHOTERICIN B
OTC/RX Status: RX
Indication(s): For empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate; and treatment of visceral leishmaniasis

Efficacy Supplemental New Drug Applications

Application #: 019651 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 19-AUG-97
Trade Name: ASACOL
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX
Efficacy Claim: Maintenance of remission of ulcerative colitis

Application#: 019828 EfficacySupplement#: 007
Type: SE5 to Original New Drug Application
Approval Date: 18-AUG-97
Trade Name: OXISTAT
Dosage Form: CREAM
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): OXICONAZOLE NITRATE
OTC/RX Status: RX
Efficacy Claim: Addition of pediatric usage information

Application#: 019828 EfficacySupplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 18-AUG-97
Trade Name: OXISTAT
Dosage Form: CREAM
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): OXICONAZOLE NITRATE
OTC/RX Status: RX
Efficacy Claim: New indication for the treatment of tinea (pityriasis) versicolor

Application #: 019858 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 07-AUG-97
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: New indication for Empirical Therapy for Febrile Neutropenic Patients

Application #: 019857 Efficacy Supplement#: 017
Type: SE1 to Original New Drug Application
Approval Date: 07-AUG-97
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: New indication for Empirical Therapy for Febrile Neutropenic Patients

Application #: 019847 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 07-AUG-97
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: New indication for Empirical Therapy for Febrile Neutropenic Patients

Application #: 020720 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: Monotherapy in type II diabetes

Application #: 020720 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: Combination with sulfonylureas in the treatment of type II diabetes

Application #: 020719 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: PRELAY
Dosage Form: TABLET Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: Monotherapy in type II diabetes

Application #: 020719 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: PRELAY
Dosage Form: TABLET Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: Combination with sulfonylureas in the treatment of type II diabetes

Application #: 020262 Efficacy Supplement#: 022
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Efficacy Claim: For the second-line treatment of AIDS-related Kaposi's sarcoma

Approvable Original New Drug Applications

Original Application #: 020742
Approvable Date: 12-AUG-97
Trade Name: BSS
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE; SODIUM CHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074979
Approval Date: 29-AUG-97
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 074840
Approval Date: 29-AUG-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074662
Approval Date: 29-AUG-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074467
Approval Date: 29-AUG-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040220
Approval Date: 29-AUG-97
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074730
Approval Date: 28-AUG-97
Trade Name: LOPERAMIDE HCL
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074544
Approval Date: 28-AUG-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064156
Approval Date: 28-AUG-97
Trade Name: CEFACLOR
Dosage Form: CAPSULE
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Original Abbreviated Application # 040187
Approval Date: 28-AUG-97
Trade Name: THIORIDAZINE HCL
Dosage Form: CONCENTRATE
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): THIORIDAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074969
Approval Date: 26-AUG-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074958
Approval Date: 26-AUG-97
Trade Name: CLOMIPRAMINE HCL
Dosage Form: CAPSULE
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074906
Approval Date: 26-AUG-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074905
Approval Date: 26-AUG-97
Trade Name: FLUOCINONIDE
Dosage Form: OINTMENT
Applicant: ALTANA INC
Active Ingredient(s): FLUOCINONIDE
OTC/RX Status: RX

Original Abbreviated Application # 074894
Approval Date: 26-AUG-97
Trade Name: DILTIAZEM HCL
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040151
Approval Date: 26-AUG-97
Trade Name: PROMETHAZINE HCL AND CODEINE PHOSPHATE
Dosage Form: SYRUP
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040109
Approval Date: 26-AUG-97
Trade Name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
Dosage Form: CAPSULE
Applicant: MIKART INC
Active Ingredient(s): ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074023
Approval Date: 22-AUG-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: GENPHARM INC PHARMACEUTICALS
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074818
Approval Date: 19-AUG-97
Trade Name: ESTAZOLAM
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ESTAZOLAM
OTC/RX Status: RX

Original Abbreviated Application # 073045
Approval Date: 19-AUG-97
Trade Name: ALBUTEROL
Dosage Form: AEROSOL, METERED
Applicant: ALPHARMA USPD INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX

Original Abbreviated Application # 040210
Approval Date: 13-AUG-97
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: PEACHTREE PHARMACEUTICALS
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074541
Approval Date: 05-AUG-97
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074704
Tentative Approval Date: 06-AUG-97
Trade Name: PROPOFOL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PROPOFOL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #:020388 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 29-AUG-97
Trade Name: NAVELBINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VINORELBINE TARTRATE
OTC/RX Status: RX

Application #:016618Labeling Supplement#:041
To Original New Drug Application
Approval Date: 29-AUG-97
Trade Name: PONDIMIN
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): FENFLURAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:050719Labeling Supplement#:001
To Original New Drug Application
Approval Date: 28-AUG-97
Trade Name: HELIDAC
Dosage Form: TABLET, CHEWABLE; TABLET; CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:050729 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 27-AUG-97
Trade Name: AMPHOTEC
Dosage Form: INJECTABLE
Applicant: SEQUUS PHARMACEUTICALS INC
Active Ingredient(s): AMPHOTERICIN B
OTC/RX Status: RX

Application #:050698 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 26-AUG-97
Trade Name: BIAXIN
Dosage Form: GRANULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #:050665Labeling Supplement#:015
To Original New Drug Application
Approval Date: 26-AUG-97
Trade Name: CEFZIL
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #:050664Labeling Supplement#:015
To Original New Drug Application
Approval Date: 26-AUG-97
Trade Name: CEFZIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #:050662 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 26-AUG-97
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #: 019527 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 22-AUG-97
Trade Name: PEPCID
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019527 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 22-AUG-97
Trade Name: PEPCID
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019462 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 22-AUG-97
Trade Name: PEPCID
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019462 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 22-AUG-97
Trade Name: PEPCID
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019222 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 22-AUG-97
Trade Name: DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): DEXTROSE
OTC/RX Status: RX

Application #:019669Labeling Supplement#:022
To Original New Drug Application
Approval Date: 21-AUG-97
Trade Name: QUESTRAN LIGHT
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Application #: 016640 Labeling Supplement#: 074
To Original New Drug Application
Approval Date: 21-AUG-97
Trade Name: QUESTRAN
Dosage Form: POWDER
Applicant: BRISTOL MYERS CO
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Application #: 018876 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 20-AUG-97
Trade Name: POTASSIUM CHLORIDE IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 018365 Labeling Supplement#: 065
To Original New Drug Application
Approval Date: 20-AUG-97
Trade Name: POTASSIUM CHLORIDE IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 017799 Labeling Supplement#: 102
To Original New Drug Application
Approval Date: 20-AUG-97
Trade Name: DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 017606 Labeling Supplement#: 113
To Original New Drug Application
Approval Date: 20-AUG-97
Trade Name: DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 016367 Labeling Supplement#: 165
To Original New Drug Application
Approval Date: 20-AUG-97
Trade Name: DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE
OTC/RX Status: RX

Application #: 019664 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 14-AUG-97
Trade Name: SELDANE-D
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): PSEUDOEPHEDRINE HYDROCHLORIDE; TERFENADINE
OTC/RX Status: RX

Application #: 018949 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 14-AUG-97
Trade Name: SELDANE
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): TERFENADINE
OTC/RX Status: RX

Application #: 016806 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 14-AUG-97
Trade Name: OVRAL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016672 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 14-AUG-97
Trade Name: OVRAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019268 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 13-AUG-97
Trade Name: CYTOTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): MISOPROSTOL
OTC/RX Status: RX

Application #: 019766 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 12-AUG-97
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 019684 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 12-AUG-97
Trade Name: PROCARDIA XL
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Application #: 019643 Labeling Supplement#: 050
To Original New Drug Application
Approval Date: 12-AUG-97
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Application #: 018482 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 12-AUG-97
Trade Name: PROCARDIA
Dosage Form: CAPSULE
Applicant: PFIZER INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Application #: 020536 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-AUG-97
Trade Name: NICOTROL
Dosage Form: PATCH
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): NICOTINE
OTC/RX Status: OTC

Application #: 020087 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-AUG-97
Trade Name: FLOXIN
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Application #: 020087 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-AUG-97
Trade Name: FLOXIN IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Application #:020087 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-AUG-97
Trade Name: FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Application #: 019735 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 11-AUG-97
Trade Name: FLOXIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Application #: 020264 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 08-AUG-97
Trade Name: MEGACE
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX

Application #: 008662 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 08-AUG-97
Trade Name: NYDRAZID
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): ISONIAZID
OTC/RX Status: RX

Application #: 020647 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: ELDEPRYL
Dosage Form: CAPSULE
Applicant: SOMERSET PHARMACEUTICALS INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020250 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: HALFAN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): HALOFANTRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020250 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: HALFAN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): HALOFANTRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020083 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020083 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 019591 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: LARIAM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MEFLOQUINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019334 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: ELDEPRYL
Dosage Form: TABLET
Applicant: SOMERSET PHARMACEUTICALS INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012754 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALATE
OTC/RX Status: RX

Application #: 012754 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALATE
OTC/RX Status: RX

Application #: 012754 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALATE
OTC/RX Status: RX

Application #:012753 Labeling Supplement#: 064
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALEATE
OTC/RX Status: RX

Application #: 012753 Labeling Supplement#: 057
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALEATE
OTC/RX Status: RX

Application #: 012753 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 06-AUG-97
Trade Name: TORECAN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIETHYLPERAZINE MALEATE
OTC/RX Status: RX

Application #: 050549 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: MEZLIN
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): MEZLOCILLIN SODIUM MONOHYDRATE
OTC/RX Status: RX

Application #: 020326 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: NEUTREXIN
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCE INC
Active Ingredient(s): TRIMETREXATE GLUCURONATE
OTC/RX Status: RX

Application #: 020326 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: NEUTREXIN
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCE INC
Active Ingredient(s): TRIMETREXATE GLUCURONATE
OTC/RX Status: RX

Application #: 020090 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: DIFLUCAN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019950 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: DIFLUCAN
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019949 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: DIFLUCAN
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019816 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ORUVAIL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST RESEARCH
Active Ingredient(s): KETOPROFEN
OTC/RX Status: RX

Application #: 018754 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ORUDIS
Dosage Form: CAPSULE
Applicant: WYETH AYERST RESEARCH
Active Ingredient(s): KETOPROFEN
OTC/RX Status: RX

Application #: 018580 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: YUTOPAR
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): RITODRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018389 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: SUSPENSION
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPA
OTC/RX Status: RX

Application #: 018389 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: SUSPENSION
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPA
OTC/RX Status: RX

Application #: 018086 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 05-AUG-97
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 #: 017810 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: PROSTIN E2
Dosage Form: SUPPOSITORY
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): DINOPROSTONE
OTC/RX Status: RX

Application #: 016016 Labeling Supplement#: 069
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOCLOR-150; ALDOCLOR-250
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CHLOROTHIAZIDE; METHYLDOPA
OTC/RX Status: RX

Application #: 013402 Labeling Supplement#: 080
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDORIL 15; ALDORIL 25; ALDORIL D30; ALDORIL D50
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; METHYLDOPA
OTC/RX Status: RX

Application #: 013401 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPATE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 013401 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPATE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 013400 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPA
OTC/RX Status: RX

Application #: 013400 Labeling Supplement#: 081
To Original New Drug Application
Approval Date: 05-AUG-97
Trade Name: ALDOMET
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPA
OTC/RX Status: RX

Application #: 050486 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: VIRA-A
Dosage Form: OINTMENT
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH
Active Ingredient(s): VIDARABINE
OTC/RX Status: RX

Application #: 050486Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 04-AUG-97
Trade Name: VIRA-A
Dosage Form: OINTMENT
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH
Active Ingredient(s): VIDARABINE
OTC/RX Status: RX