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Drug Approvals for July 1998
Definitions and Notes
July 1998
Original New Drug Applications
Original Application #: 020822
Approval Date: 17-JUL-98
Trade Name: CELEXA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): CITALOPRAM HYDROBROMIDE
OTC/RX Status: RX
Indication(s): TREATMENT OF DEPRESSION
Original Application #: 020785
Approval Date: 16-JUL-98
Trade Name: THALOMID
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: CELGENE CORP
Active Ingredient(s): THALIDOMIDE
OTC/RX Status: RX
Indication(s): Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences
Original Application #: 020860
Approval Date: 13-JUL-98
Trade Name: LEVLITE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX
Indication(s): Prevention of Pregnancy
Original Application #: 020521
Approval Date: 01-JUL-98
Trade Name: INFASURF
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: ONY INC
Active Ingredient(s): CALFACTANT
OTC/RX Status: RX
Indication(s): Prevention and treatment of Respiratory Distress Syndrome (RDS) in neonates
Efficacy Supplemental New Drug Applications
Application #: 020578 Efficacy Supplement #: 003
Type: SE1 to Original New Drug Application
Approval Date: 27-JUL-98
Trade Name: ZOLADEX
Dosage Form: PELLET, IMPLANT
Applicant: ZENECA LTD
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX
Efficacy Claim: Provides for the use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate
Application #: 019726 Efficacy Supplement #: 024
Type: SE1 to Original New Drug Application
Approval Date: 27-JUL-98
Trade Name: ZOLADEX
Dosage Form: PELLET, IMPLANT
Applicant: ZENECA LTD
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX
Efficacy Claim: Provides for the use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate
Application #: 020406 Efficacy Supplement #: 021
Type: SE2 to Original New Drug Application
Approval Date: 20-JUL-98
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim: Provides for a 10-day dosing regimen for triple therapy, Prevacid in combination with clarithromycin and amoxicillin, for the eradication of Helicobacter pylori in patients with duodenal ulcer disease
Application #: 020702 Efficacy Supplement #: 003
Type: SE1 to Original New Drug Application
Approval Date: 10-JUL-98
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: WARNER LAMBERT EXPORT LTD
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Efficacy Claim: Provides for the use as an adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Frederickson Type IV)
Application #: 020702 Efficacy Supplement #: 005
Type: SE1 to Original New Drug Application
Approval Date: 10-JUL-98
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: WARNER LAMBERT EXPORT LTD
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Efficacy Claim: Provides for the use by patients with primary dysbetalipoproteinemia (Frederickson Type III) who do not respond adequately to diet
Approvable Original New Drug Applications
Original Application #: 020844
Approvable Date: 20-JUL-98
Trade Name: TOPAMAX
Dosage Form: CAPSULE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Original Abbreviated Application # 075020
Approval Date: 30-JUL-98
Trade Name: HYDROXYUREA
Dosage Form: CAPSULE
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX
Original Abbreviated Application # 074552
Approval Date: 30-JUL-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040267
Approval Date: 30-JUL-98
Trade Name: BUTALBITAL,ACETAMINOPHEN AND CAFFEINE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE
OTC/RX Status: RX
Original Abbreviated Application # 074653
Approval Date: 29-JUL-98
Trade Name: HYDROMORPHONE HCL
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074597
Approval Date: 29-JUL-98
Trade Name: HYDROMORPHONE HCL
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075168
Approval Date: 28-JUL-98
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 074945
Approval Date: 28-JUL-98
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074944
Approval Date: 28-JUL-98
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 075105
Approval Date: 23-JUL-98
Trade Name: INDAPAMIDE
Dosage Form: TABLET
Applicant: ALPHAPHARM PARTY LTD
Active Ingredient(s): INDAPAMIDE
OTC/RX Status: RX
Original Abbreviated Application # 075025
Approval Date: 23-JUL-98
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: AKORN INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 074974
Approval Date: 23-JUL-98
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: AKORN INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 075034
Approval Date: 20-JUL-98
Trade Name: GEMFIBROZIL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient (s): GEMFIBROZIL
OTC/RX Status: RX
Original Abbreviated Application # 075028
Approval Date: 20-JUL-98
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX
Original Abbreviated Application # 074931
Approval Date: 20-JUL-98
Trade Name: IBUPROFEN
Dosage Form: TABLETS
Applicant: NOVOPHARM LTD
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Original Abbreviated Application # 074859
Approval Date: 09-JUL-98
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074752
Approval Date: 09-JUL-98
Trade Name: DILTIAZEM HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074862
Approval Date: 07-JUL-98
Trade Name: MORPHINE SULFATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: AB GENERICS LP
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 075160
Approval Date: 06-JUL-98
Trade Name: METOPROLOL TARTRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): METOPROLOL TARTRATE
OTC/RX Status: RX
Original Abbreviated Application # 074782
Approval Date: 06-JUL-98
Trade Name: IBUPROFEN
Dosage Form: CAPSULE
Applicant: PRIVATE FORMULATIONS INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Original Abbreviated Application # 074769
Approval Date: 02-JUL-98
Trade Name: MORPHINE SULFATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: AB GENERICS LP
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 074616
Tentative Approval Date: 15-JUL-98
Trade Name: AMRINONE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): AMRINONE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 018473 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 30-JUL-98
Trade Name: VENTOLIN
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX
Application #: 020033 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 29-JUL-98
Trade Name: LOTENSIN HCT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 019851 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 29-JUL-98
Trade Name: LOTENSIN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): BENAZEPRIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017820 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 29-JUL-98
Trade Name: DOBUTREX
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020297 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 28-JUL-98
Trade Name: COREG
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CARVEDILOL
OTC/RX Status: RX
Application #: 050678 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 22-JUL-98
Trade Name: DYNABAC
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): DIRITHROMYCIN
OTC/RX Status: RX
Application #: 020720 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 22-JUL-98
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Application #: 020668 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 22-JUL-98
Trade Name: LEXXEL
Dosage Form: TABLET
Applicant: ASTRA MERCK INC
Active Ingredient(s): ENALAPRIL MALEATE; FELODIPINE
OTC/RX Status: RX
Application #: 050662 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 21-JUL-98
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Application #: 020406 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 20-JUL-98
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Application #: 019979 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 15-JUL-98
Trade Name: TICLID
Dosage Form: TABLET
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019979 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 15-JUL-98
Trade Name: TICLID
Dosage Form: TABLET
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018118 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 15-JUL-98
Trade Name: LANOXICAPS
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): DIGOXIN
OTC/RX Status: RX
Application #: 009330 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 15-JUL-98
Trade Name: LANOXIN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): DIGOXIN
OTC/RX Status: RX
Application #: 020758 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 14-JUL-98
Trade Name: AVAPRO HCT
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; IRBESARTAN
OTC/RX Status: RX
Application #: 019834 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 14-JUL-98
Trade Name: PLENDIL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRA MERCK INC
Active Ingredient(s): FELODIPINE
OTC/RX Status: RX
Application #: 019614 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 14-JUL-98
Trade Name: VERELAN
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 016709 Labeling Supplement #: 123
To Original New Drug Application
Approval Date: 10-JUL-98
Trade Name: ORTHO-NOVUM 1/50 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): MESTRANOL; NORETHINDRONE
OTC/RX Status: RX
Application #: 012728 Labeling Supplement #: 188
To Original New Drug Application
Approval Date: 10-JUL-98
Trade Name: ORTHO-NOVUM 1/150 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): MESTRANOL; NORETHINDRONE
OTC/RX Status: RX
Application #: 016647 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 01-JUL-98
Trade Name: QUINAGLUTE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): QUINIDINE GLUCONATE
Application #: 011642 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 01-JUL-98
Trade Name: CARDIOQUIN
Dosage Form: TABLET
Applicant: PURDUE FREDERICK COMPANY
Active Ingredient(s): QUINIDINE POLYGALACTURONATE
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Date created: Aug 10, 1998; last updated: June 20, 2005 |
