http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
FDA Drug Approvals List April 2000 - Drug Approvals for April 2000 Definitions and Notes Original New Drug Applications Original Application #: 021025 Approval Date: 21-APR-00 Trade Name: EXELON Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): RIVASTIGMINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate...
Prescription and OTC Drug Product List 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch)...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND...
DDPA February 1996 IT IS USEFUL IN THE DELINEATION OF REGIONS OF REVERSIBLE MYOCARDIAL ISCHEMIA IN THE PRESENCE OR ABSENCE OF INFARCTED MYOCARDIUM] 11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE 13-FEB-96 (TABLET) FLORENCE, KY 2.5MG (SUPPL-010) 41042 AMPHETAMINE SULFATE 2.5MG DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE 2.5MG (AMPHETAMINE) 11-522 ADDERALL 20 RICHWOOD PHARM...
2001 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2001 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Reference Listed Drug Labeling Approved in March 2000 TRADENAME ACTIVE/DOSAGE FORM NDA# SUPP# FIRM MAR DIOVAN HCT Valsartan/HCTZ/tab 20-818 S-006 Novartis Pharms 1 TIMOPTIC in OCCUDOSE Timolol maleate/opth.sol 19-463 S-020 Merck 2 EFFEXOR Venlafaxine HCl 20-151 S-014 Wyeth Ayerst 3 EFFEXOR XR Venlafaxine HCl 20-699 S-008 Wyeth Ayerst 3 TECZEM Diltiazem malate/enalapril maleate 20-507 S-002 Aventis Pharms 3 PROPULSID Cisapride/oral sol...
author: USERNAME
