Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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,...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
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...
http://www.fda.gov/cder/foi/appletter/1999/40317ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/1999/40319ltr.pdf page 1
H: 30.PDF ANDA 40- 230 February 26, 1999 Lannett Company IncDicyclomine Hydrochloride Tablets USP, 20 mg
author: Unknown
H: 30.PDF page 1
author: Unknown
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...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library...
Anticholinergics (antispasmodics) for irritable bowel syndrome - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Anticholinergics (antispasmodics) for irritable bowel syndrome - [Medication] - Quest Diagnostics Patient Health Library Anticholinergics (antispasmodics) for irritable bowel syndrome - [Medication] - Quest Diagnostics Patient Health Library Anaspaz,...
Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library Anticholinergics and antispasmodics for urinary incontinence in men - [Medication] - Quest Diagnostics Patient Health Library...
Specificity Table TOX.xls Tested (ng/ ml) BAL Dimercaprol Chelating agent 100,000 Barbitone Barbital Barbiturate 100,000 BAR 150 Baycol Cerivastatin Antihyperlipidemic 10,000 BDB BDB( d, l- 1-( 3,4- Methylenedioxyphenyl)- 2- Butanamine) MBDB metabolite 100,000 AMP 2,500 Benadryl Diphenhydramine Antihistamine/ Sedative 1,000,000 Benemid Probenecid Antigout 100,000 Bentyl Dicyclomine Anticholinergic...
author: Biosite Incorporated
Specificity Table TOX.xls page 4
author: Biosite Incorporated
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
Drug Approvals - D ANDA 75-371 8/27/99 9/2/99 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Gensia Sicor Pharmaceuticals ANDA 75-259 8/27/98 9/2/98 - - Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg ICN Pharmaceuticals NDA 16-721/S-074 6/14/01 11/22/02 Daraprim (pyrimethamine) Tablets, 25 mg, Rx GlaxoSmithKline NDA 8-578/S16 11/18/03 11/25/03 12/1/03 - Daraprim (pyrimethamine)...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt BISACODYL 2277 17-May-74 ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS 2303 11-Jul-74 SOLMAG S.P.A DICYCLOMINE HYDROCHLORIDE 2314 08-Aug-74 CHATTEM CHEMICALS INC AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE 2318 23-Aug-74 TAKEDA CHEMICAL INDUSTRIES LTD FOLIC ACID 2364 26-Nov-74 AVENTIS PHARMA SA NORGESTERAL ACETATE OXIME 2368 10-Dec-74 INDUSTRIA CHIMICA MILANESE SPA ...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATIONDICYCLOMINE ...
ANDA Approvals June 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - June 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-453 DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS - BEDFORD LABORATORIES 6/9/2003- 2 75-992 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)...
author: OGD
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE ...
author: AUTHOR
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
