http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
Reference Listed Drug Labeling Approved in February 2000 Food and Drug Administration • Center for Drug Evaluation and Research Office of Generic Drugs Search Reference Listed Drug Labeling Approved in February 2000 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat...
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FDA Drug Approvals List February 2000 Dosage Form: GRANULE Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE OTC/RX Status: RX Application #: 020847 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 04-FEB-00 Trade Name: ESCLIM Dosage Form: FILM, CONTROLLED RELEASE Applicant: WOMEN FIRST HEALTHCARE INC Active Ingredient(s): ESTRADIOL OTC...
CDER 1997 Report to the Nation Center for Drug Evaluation and Research CDER 1997 Report to the Nation Improving Public Health Through Human Drugs U
author: Center for Drug Evaluation and Research
CDER 1997 Report to the Nation page 12
author: Center for Drug Evaluation and Research
DDPA August 1996 20-619 BETOPTICPILO ALCON BETAXOLOL HYDROCHLORIDE 01-AUG-96 (SUSPENSION) FORT WORTH, TX 0.25% 76134 PILOCARPINE HYDROCHORIDE 1.75% (ADRENOCEPTOR ANTAGONIST/ CHOLINERGIC AGONIST) 20-587 SCLEROSOL BRYAN TALC 09-AUG-96 (AEROSOL, POWDER) WOBURN, MA 4GM 01801 (MINERAL) 20-592 ZYPREXA LILLY OLANZAPINE 30-AUG-96 (TABLET) INDIANAPOLIS, IN 2.5MG 46285 5MG 7.5MG 10MG (ANTIPSYCHOTIC...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
Drug Approvals for December 1997 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...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
Drug Approval Package: 020587 Sclerosol FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Sclerosol Company:-Bryan Application No.:-020587 Approval Date:-12/24/1997 Approval Letter(s) - Medical Review(s)- - Part 1 - Part 2 - Chemistry Review(s) - - Pharmacology Review(s) - Statistical Review(s) - Microbiology Review(s) -- Clinical Pharmacology Biopharmaceutics Review(s) -...
1997 New Drug Application (NDA) 018381/S027 4/16/1997 11/ 20/1997 Requip/Ropinirole Hydrochloride Approval/Approvable Letter [502 KB] Medical Review(s) Part 1 [4.8 MB], Part 2 [3.9 MB], Part 3 [4.4 MB] Chemistry Review(s)/EA(Fonsi) [4.2 MB] Pharmacology Review(s) Part 1 [4.4 MB], Part 2 [3.2 MB] Statistical Review(s) [3.7 MB] Clinical Pharmacology Biopharmaceutics Review(s) [1.4 MB] Administrative Documents [3.2 MB...
pike02.PDF The Pike, February 13, 1998 Page 1 By Ted Sherwood The Center approved 431 generic products in 1997, including 30 that represent the first time a generic drug was available for the brand name product
author: CDER User
pike02.PDF page 8
author: CDER User
