Drug Approvals - A Ativan (Lorazepam) Injection, - Wyeth Laboratories- NDA 96-989/S35 & S36- 12/12/01- 4/11/03 Activella (Estradiol/Norethindrone Acetate) Tablets, Rx Novo Nordisk Pharmaceuticals, Inc
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY" 10247 17-May-93 DIOSYNTH BV "PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS" 10253 12-May-93 NEULAND LABORATORIES LTD "ALBUTEROL BASE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA" 10262 25-May-93 JETPHARMA SA "CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA, SWITZERLAND" 10264...
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
../99/21057_Antagon_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Antagon (Ganirelix Acetate) Company:--Organon, Inc
author: USERNAME
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in...
http://www.fda.gov/cder/foi/label/2001/21057s2lbl.PDF (ganirelix acetate) Injection FOR SUBCUTANEOUS USE ONLY DESCRIPTION Antagon™ (ganirelix acetate) Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin- releasing hormone (GnRH)ganirelix acetate) Injection is indicated for the inhibition of...
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D:\Data\My Documents\NDA\N21057\N21057S02APltr.doc Stokman: Please refer to your supplemental new drug application dated March 26, 2001, received March 27, 2001, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Antagon™ (ganirelix acetate) Injection
author: Jeanine Best
D:\Data\My Documents\NDA\N21057\N21057S02APltr.doc page 1
author: Jeanine Best
Antagon Consumer Information Antagon Injection® Brand Name: Antagon Injection® Active Ingredient: - ganirelix acetate Strength(s): 250 mcg/0.5 ml Dosage Form(s): - Injection Company Name: -- Organon, Inc
N21057FPL.PDF Ganirelix PI 1 Antagonae (ganirelix acetate) Injection 1 FOR SUBCUTANEOUS USE ONLY 2 3 DESCRIPTION 4 Antagonae (ganirelix acetate) Injection is a synthetic decapeptide with high antagonistic 5 activity against naturally occurring gonadotropin- releasing hormone (GnRH)ganirelix antibody 176 formation have not been...
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