Drug Approvals - Z NDA 17-386/S-032 8/10/01 6/16/03 - - Zavesca (Miglustat) Capsules, 100 mg, Rx Actelion Pharmaceuticals NDA 21-348 7/31/03 8/15/03 8/15/03 12/15/03 Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg Wyeth-Ayerst Laboratories NDA 19-982/S5 6/23/98 8/1/01 Zebeta (Bisoprolol Fumarate) Tablets, 5 & 10 mg Lederle Laboratories NDA 19-982/S6 2/19/98 8/1/01...
1996 and Older - New Drug Application (NDA) 018654/S018 S029 S030 11/31/1996 3/18/1997 11/20/1997 Wellbutrin Glaxo Wellcome 018644/S10,12, 13 10/31/96 6/17/2003 Xanax Tablets/Alprazolam [2 MB] Pharmacia and Upjohn 018276/S033 11/26/1996 11/20/1997 Zantac Syrup/Ranitidine HCl [1 MB] Glaxo-Wellcome 019675 12/30/1988 2/4/1998 Zebeta (Bisoprolol Fumarate) Tablets , 5 & 10 mg Lederle Laboratories 19-982 6/11/93 8...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
19982_Probeta.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zebeta (Bisoprolol Fumarate) Tablets Company:- Lederle Laboratories Application No.:- 19-982 Approval Date:-7/31/92 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) - Clinical...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
1997 New Drug Application (NDA) 20692 9/19/1997 5/13/1998 Seroquel/Quetiapine Fumarate Approval Letter [308 KB] Medical Review(s) Part 1 [3 MB] Part 2 [4.2 MB] Part 3 [4.2 MB] Chemistry Review(s)/EA(Fonsi) [1.2 MB] Pharmacology Review(s) Part 1 [3.3 MB], Part 2 [4.2 MB], Part 3 [4.9] Statistical Review(s) [2.3 MB] Administrative Documents [699 KB] Zeneca Pharmaceuticals 20639 9/26/1997 5/12/1998 Skelid...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
C:\Data\labeling\20186_s015_19982_s010_ap.doc page 1
author: Melissa Robb
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
http://www.fda.gov/cder/foi/appletter/2000/75643ltr.pdf ANDA 75- 643 November 16, 2000 Eon Labs Manufacturing, IncBisoprolol Fumarate Tablets, 5 mg and 10 mg
http://www.fda.gov/cder/foi/appletter/2000/75643ltr.pdf page 1
DDPA May 1995 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG 08543 20MG 40MG (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 18-206* LO/OVRAL-28 WYETH AYERST LABS ETHINYL ESTRADIOL 03-MAY-95 AND FERROUS FUMARATE PHILADELPHIA, PA 0.03MG ...
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...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENOCARD...
Beta-blockers for heart failure - [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 Beta-blockers for heart failure - [Medication] - Quest Diagnostics Patient Health Library Beta-blockers for heart failure - [Medication] - Quest Diagnostics Patient Health Library beta blockers, beta blocking agent, beta-adrenergic blocking agent, beta...
Beta-blockers for heart failure - [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 Beta-blockers for heart failure - [Medication] - Quest Diagnostics Patient Health Library Beta-blockers for heart failure - [Medication] - Quest Diagnostics Patient Health Library beta blockers, beta blocking agent, beta-adrenergic blocking agent, beta...
Beta-blockers for mitral valve prolapse - [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 Beta-blockers for mitral valve prolapse - [Medication] - Quest Diagnostics Patient Health Library Beta-blockers for mitral valve prolapse - [Medication] - Quest Diagnostics Patient Health Library Heart and circulation, Heart problems, Atenolol, balloon mitral valve...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENO...
Reference Listed Drug Labeling Approved in April 2000 Tradename Active Ingredient(s) / Dosage Form NDA/Sup# Firm April AMICAR Aminocaproic acid INJ 15-229 030 Immunex 3 AMICAR Aminocaproic acid TAB 15-197 034 Immunex 3 LO/OVRAL Norgestrel/ethinyl estradiol TAB 17-612 031 Wyeth Ayerst 3 NORDETTE-21 Levonorgestrel/ethinyl estradiol TAB 18-668 030 Wyeth Ayerst 3 PREVEN Levonorgestrel/ ethinyl estradiol TAB 20-946 005 Gynetics 3 CALCIJEX...
author: GraceJ
Drug Approvals - B ANDA: 75-644 6/26/01 - - - Bisoprolol Fumarate Tablets, 5 mg and 10 mg, Rx Eon Labs Manfacturing, IncBisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Teva Pharmaceuticals ANDA: 75-686 1/19/01 3/5/01 - - Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN TOLUCA, ESTADO DE MEXICO, MEXICO" 8024 12-Apr-89 E MERCK BISOPROLOL FUMARATE 2:1 AS MFG
