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, SECRETIN...
Reference Listed Drug Labeling Approved in June 2002 Food and Drug Administration • Center for Drug Evaluation and Research Office of Generic Drugs Search Reference Listed Drug Labeling and Efficacy Supplements Approved in July 2002 Click on appropriate hyperlink below to view available source document in PDF format Approval Date Product Name Source Documents Active Ingredient(s)/Dosage Form Document ID No
author: USERNAME
FDA Drug Approvals List July 2002 PEDIATRIC Dosage Form: INJECTABLE Applicant: NEOSAN PHARMACEUTICALS Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 018154 Labeling Supplement #: 023 To Original New Drug...
C:\Data\Wpfiles\Labeling Initiative\n20652.slr.003.letter.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 20- 652/ S- 003 Nycomed Amersham Imaging Attention: David Risley Director, Regulatory Affairs 101 Carnegie Center Princeton, NJ 08540- 6231 Dear Mr
author: Kyong Cho
C:\Data\Wpfiles\Labeling Initiative\n20652.slr.003.letter.doc page 1
author: Kyong Cho
Medicinal Products with a Community Marketing authorisation - Status October 2002 page 6 List Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: List
Medicinal Products with a Community Marketing authorisation, Status-September 2002 page 6 Table Medicinal Products granted a Community Marketing Authorisation under the Centralised Procedure Product a) Brandname b) INN c) Part A/ B Company a) Name b) Origin Therapeutic Area a) ATC b) Indication Presentation a) Form b) Strengths c) Number of Presentations EMEA/ CPMP a) Validation b) Opinion ...
author: EMEA
subject: Table
duplicates:http://www.emea.eu.int/pdfs/general/direct/listprod/1640502en.pdf
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX Indication(s)...
FDA Drug Approvals List- April 1999 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:...
http://www.emea.eu.int/pdfs/human/press/pr/050297en.pdf The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 502/ 97 20 June 1997 ...
author: Jerry Wells
http://www.emea.eu.int/pdfs/human/press/pr/050297en.pdf page 4 The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html ANNEX II to CPMP June 1997 ...
author: Jerry Wells
http://www.emea.eu.int/pdfs/human/press/pr/050297en.pdf page 1 The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 502/ 97 20 June 1997 ...
author: Jerry Wells
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to...
