Drug Approvals for April 1999

April 1999

Original New Drug Applications

Original Application #: 020766
Approval Date: 23-APR-99
Trade Name: XENICAL
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ORLISTAT
OTC/RX Status: RX
Indication(s): For the use of Xenical Capsules for obesity management including weight loss and weight maintenance when used in conjunction with a reduced calorie diet and indicated to reduce the risk of weight regain after prior weight loss.

Original Application #: 050760
Approval Date: 15-APR-99
Trade Name: AMOXIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX
Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h

Original Application #: 020924
Approval Date: 06-APR-99
Trade Name: CERNEVIT-12
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER FOR RECONSTITUTION;INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): ALPHA-TOCOPHEROL; ASCORBIC ACID; BIOTIN, D-; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A
OTC/RX Status: RX
Indication(s): For the use of Cernevit-12 for a daily multivitamin maintenance dosage for adults and children age 11 years and above receiving parenteral nutrition and for situations where the administration by the intravenous route is required

Original Application #: 021041
Approval Date: 01-APR-99
Trade Name: DEPOCYT
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: DEPOTECH CORP
Active Ingredient(s): CYTARABINE LIPOSOME
OTC/RX Status: RX
Indication(s): For the intrathecal treatment of lymphomatous meningitis

Efficacy Supplemental New Drug Applications

Approvable Original New Drug Applications

Original Application #: 020836
Approvable Date: 30-APR-99
Trade Name: AZMACORT
Dosage Form: INHALANT
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX

Original Application #: 020737
Approvable Date: 19-APR-99
Trade Name: ECHOGEN
Dosage Form: INJECTABLE
Applicant: SONUS PHARMACEUTICALS
Active Ingredient(s): PERFLENAPENT
OTC/RX Status: RX

Original Application #: 020990
Approvable Date: 15-APR-99
Trade Name: ZOLOFT
Dosage Form: CONCENTRATE
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075196
Approval Date: 30-APR-99
Trade Name: ALPROSTADIL
Dosage Form: INJECTABLE
Applicant: GENSIA INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX

Original Abbreviated Application # 074916
Approval Date: 30-APR-99
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Original Abbreviated Application # 075382
Approval Date: 30-APR-99
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: CARLSBAD TECHNOLOGY INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074988
Approval Date: 30-APR-99
Trade Name: ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
Dosage Form: TABLET
Applicant: JEROME STEVENS PHARMACEUTICALS INC
Active Ingredient(s): ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
OTC/RX Status: RX

Original Abbreviated Application # 075106
Approval Date: 29-APR-99
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: MERIDIAN MEDICAL TECHNOLOGIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040316
Approval Date: 28-APR-99
Trade Name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODONE BITARTRATE
Dosage Form: TABLET
Applicant: MIKART INC
Active Ingredient(s): DIHYDROCODEINE BITARTRATE; ACETAMINOPHEN; CAFFEINE
OTC/RX Status: RX

Original Abbreviated Application # 075374
Approval Date: 27-APR-99
Trade Name: DIFLORASONE DIACETATE
Dosage Form: OINTMENT
Applicant: ALTANA INC
Active Ingredient(s): DIFLORASONE DIACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075088
Approval Date: 27-APR-99
Trade Name: CROMOPTIC
Dosage Form: SOLUTION
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075228
Approval Date: 26-APR-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 075222
Approval Date: 26-APR-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTION
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074847
Approval Date: 23-APR-99
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065018
Approval Date: 23-APR-99
Trade Name: CEFADROXIL
Dosage Form: TABLET
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): CEFADROXIL
OTC/RX Status: RX

Original Abbreviated Application # 075111
Approval Date: 22-APR-99
Trade Name: IPRATROPIUM BROMIDE
Dosage Form: SOLUTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075367
Approval Date: 22-APR-99
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: PERRIGO CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Original Abbreviated Application # 040326
Approval Date: 21-APR-99
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075329
Approval Date: 20-APR-99
Trade Name: MICONAZOLE NITRATE COMBINATION PACK
Dosage Form: SUPPOSITORY
Applicant: PERRIGO CO
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC

Original Abbreviated Application # 075329
Approval Date: 20-APR-99
Trade Name: MICONAZOLE NITRATE COMBINATION PACK
Dosage Form: CREAM
Applicant: PERRIGO CO
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC

Original Abbreviated Application # 075138
Approval Date: 20-APR-99
Trade Name: VERAPAMIL HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074686
Approval Date: 20-APR-99
Trade Name: GLYBURIDE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): MICRONIZED
OTC/RX Status: RX

Original Abbreviated Application # 074926
Approval Date: 16-APR-99
Trade Name: M-ZOLE 3 COMBINATION PACK
Dosage Form: EMULSION, CREAM
Applicant: ALPHARMA US PHARMACEUTICAL DIVISION
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC

Original Abbreviated Application # 074895
Approval Date: 16-APR-99
Trade Name: AMIODARONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: NOVOPHARM N.C., INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065016
Approval Date: 08-APR-99
Trade Name: AMOXICILLIN
Dosage Form: CAPSULE
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

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

Labeling Supplements to Original New Drug Applications

Application #: 018613 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 30-APR-99
Trade Name: OVIDE
Dosage Form: LOTION
Applicant: MEDICIS PHARMACEUTICAL CORP
Active Ingredient(s): MALATHION
OTC/RX Status: RX

Application #: 020680 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 29-APR-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 050616 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 28-APR-99
Trade Name: TOBRADEX
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): TOBRAMYCIN; DEXAMETHASONE
OTC/RX Status: RX

Application #: 050592 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 28-APR-99
Trade Name: TOBRADEX
Dosage Form: SUSPENSION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DEXAMETHASONE; TOBRAMYCIN
OTC/RX Status: RX

Application #: 020615> Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 27-APR-99
Trade Name: DURACLON
Dosage Form: INJECTABLE
Applicant: ROXANE LABORATORIES
Active Ingredient(s): CLONIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050591 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 22-APR-99
Trade Name: BACTROBAN OINTMENT
Dosage Form: OINTMENT
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): MUPIROCIN
OTC/RX Status: RX

Application #: 020255 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-APR-99
Trade Name:DOBUTAMINE HCL IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019970 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 21-APR-99
Trade Name: NITROGLYCERIN IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 012616 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 21-APR-99
Trade Name: ALDACTAZIDE
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020758 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 20-APR-99
Trade Name: AVALIDE
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): IRBESARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020164 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 20-APR-99
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #: 019937 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 20-APR-99
Trade Name: ADENOCARD
Dosage Form: INJECTABLE
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): ADENOSINE
OTC/RX Status: RX

Application #: 018343 Labeling Supplement#: 073
To Original New Drug Application
Approval Date: 20-APR-99
Trade Name: CAPOTEN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX

Application #: 020646 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 16-APR-99
Trade Name: GABITRIL
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): TIAGABINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019890 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 16-APR-99
Trade Name: STADOL NS
Dosage Form: SPRAY, METERED
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Application #: 019890 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 16-APR-99
Trade Name: STADOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Application #: 019008 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 16-APR-99
Trade Name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN FLEXIBLE CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): BRETYLIUM TOSYLATE
OTC/RX Status: RX GOSERELIN ACETATE
OTC/RX Status: RX

Application #: 020680 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 12-APR-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020570 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 12-APR-99
Trade Name: QUADRAMET
Dosage Form: INJECTABLE
Applicant: CYTOGEN CORP
Active Ingredient(s): SAMARIUM SM 153 LEXIDRONAM PENTASODIUM
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 12-APR-99
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020680 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 09-APR-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 09-APR-99
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020652 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 02-APR-99
Trade Name: TESLASCAN
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): MANGAFODIPIR TRISODIUM
OTC/RX Status: RX

Application #: 019557 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 02-APR-99
Trade Name: VEPESID
Dosage Form: CAPSULE
Applicant: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX

Application #: 018768 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 02-APR-99
Trade Name: VEPESID
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX

Application #: 020221 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 01-APR-99
Trade Name: ETHYOL
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCE INC
Active Ingredient(s): AMIFOSTINE
OTC/RX Status: RX

May 21., 1999
http://www.fda.gov/cder/da/da0499.htm