http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, QUARZAN to SYPRINE
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS QUARZAN to SYPRINE Trade Name Generic QUARZAN *Clidinium QUESTRAN Cholestyramine QUINAGLUTE Quinidine RAXAR Grepafloxacin REBETRON Ribavirin RECOMBIVAX HB Hepatitis B vaccine REGITINE Phentolamine REGLAN Metoclopramide RELAFEN Nabumetone RELENZA Zanamivir REOPRO Abciximab REQUIP...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Calcifediol to Cytarabine
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Calcifediol to Cytarabine Generic Trade Name Calcifediol CALDEROL Calcitonin-human CIBACALCIN Calcitonin-salmon CALCIMAR Calcitriol ROCALTROL Capreomycin CAPASTAT Capsaicin ZOSTRIX Captopril CAPOTEN Carbamazepine TEGRETOL Carbenicillin GEOCILLIN Carbidopa-levodopa SINEMET Carbinoxamine CLISTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, QUARZAN to SYPRINE
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS QUARZAN to SYPRINE Trade Name Generic QUARZAN *Clidinium QUESTRAN Cholestyramine QUINAGLUTE Quinidine RAXAR Grepafloxacin REBETRON Ribavirin RECOMBIVAX HB Hepatitis B vaccine REGITINE Phentolamine REGLAN Metoclopramide RELAFEN Nabumetone RELENZA Zanamivir REOPRO Abciximab REQUIP...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Calcifediol to Cytarabine
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Calcifediol to Cytarabine Generic Trade Name Calcifediol CALDEROL Calcitonin-human CIBACALCIN Calcitonin-salmon CALCIMAR Calcitriol ROCALTROL Capreomycin CAPASTAT Capsaicin ZOSTRIX Captopril CAPOTEN Carbamazepine TEGRETOL Carbenicillin GEOCILLIN Carbidopa-levodopa SINEMET Carbinoxamine CLISTIN...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
PROPARACAINE HCL 2712 03-Aug-76 PHARMACIA AND UPJOHN INC "HEPARIN, SODIUM U.S.P." 2716 10-Aug-76 SMITHKLINE CORP "CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND." 2719 09-Aug-76 PLANTEX LTD CHEM AND PHARM WORKS AMITRIPTYLINE HCL 2726 05-Aug-76 SCHERING AG NORETHINDRONE 2736 19-Jul-76 ROUSSEL-UCLAF "DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE."...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
3M PHARMS CORDRAN (FLURANDRENOLIDE) TAPE ORGANICS DIV LA GRANGE INC ESTERIFIED ESTROGENS USP POWDER ORGANICS DIV LA GRANGE INC CONJUGATED ESTROGEN USP POWDER GANES CHEMICALS INC PROPOXYPHENE HYDROCHLORIDE AVENTIS PHARMA SA HYDROCORTISONE USP MALLINCKRODT INC OXYCODONE TEREPHTHALATE SOLMAG S.P.A CLIDINIUM BROMIDE PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRY...
ANDAs: Impurities in Drug Substances, Guidance Document
Food and Drug Administration Center for Drug Evaluation and Research Guidance Document Search Guidance for Industry ANDAs: Impurities in Drug Substances [ Acrobat version of this document ] U.S ICH Q3A provides recommendations for (1) inclusion of information regarding specified impurities in certain new drug applications (NDAs) (identified and unidentified impurities in...
author: Paul Stauffer
ANDAs: Impurities in Drug Substances
Guidance for Industry ANDAs: Impurities in Drug Substances U Qualifying impurities found at higher levels in a drug substance used in an ANDA than found in the related USP monograph, scientific literature, or innovator material; Other materials (e ANALYTICAL PROCEDURES The DMF or abbreviated application should include documented evidence that the analytical procedures are...
author: CDER
subject: Guidance Document
ANDAs: Impurities in Drug Substances page 12
author: CDER
subject: Guidance Document
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 PHARMACEUTICALS INC...