Drug Approvals - A
NDA 18-662/S-038 5/1/00 1/17/01 - - Acebutolol Hydrochloride Capsules,200 mg (base) and 400 mg (base) ANDA 75-819 9/11/02 Amantadine Hydrochloride Syrup USP, 50 mg and 5 mL Morton Grove Pharmaceuticals ANDA 75-060 12/24/98 12/24/98 - - Amantadine Hydrochloride Tablets, 100 mg, Rx Upsher-Smith Laboratories, Inc NDA 5-619/S-016 3/30/01 5/16/02 - - Aminosyn...
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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
4134 31-Mar-81 MALLINCKRODT INC "GALLIUM CHL GA-67--MFGR AT MARYLAND HGTS., MISSOURI CYCLOTRON FACILITY" 4136 14-Apr-81 PERKINELMER LIFE SCIENCES "INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES" 4139 27-Mar-81 SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HcL 4141 24-Mar-81 MAY AND BAKER LTD ACEBUTOLOL HCL/SECTRAL 4148 28-Apr-81...
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 CORPORATION MALLINCKRODT INC GALLIUM CHL GA-67--MFGR AT MARYLAND HGTS., MISSOURI CYCLOTRON...
Prescription and OTC Drug Product List 6/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACEBUTOLOL HYDROCHLORIDE CAPSULE; ORAL SECTRAL -A- AB ESP PHARMA EQ 200MG BASE N18917 001 DEC 28, 1984 JUL CAHN -A- AB + EQ 400MG BASE N18917 003 DEC 28, 1984 JUL CAHN -D- AB WYETH AYERST EQ 200MG BASE N18917 001 DEC 28, 1984 JUL CAHN -D- AB + EQ 400MG BASE N18917 003 DEC 28, 1984 JUL CAHN ACETAMINOPHEN; HYDROCODONE...
http://www.merck.com/product/usa/pi_circulars/a/aggrastat/aggrastat_pi.pdf
1 9123311 07- 19- 29- 498 AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION PREMIXED) AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION) DESCRIPTION AGGRASTAT * (tirofiban hydrochloride), a non- peptide antagonist of the platelet glycoprotein (GP) IIb/ IIIa receptor, inhibits platelet aggregation There were no clinically significant effects of co- administration of...
http://www.merck.com/product/usa/pi_circulars/a/aggrastat/aggrastat_pi.pdf page 7
http://www.fda.gov/cder/foi/label/2001/20913s6lbl.pdf
9123306 07- 19- 11- 970 1 AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION PREMIXED) AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION) DESCRIPTION AGGRASTAT * (tirofiban hydrochloride), a non- peptide antagonist of the platelet glycoprotein (GP) IIb/ IIIa receptor, inhibits platelet aggregation AGGRASTAT ® (Tirofiban Hydrochloride Injection Premixed)...
http://www.fda.gov/cder/foi/label/2001/20913s6lbl.pdf page 6
http://www.fda.gov/cder/foi/appletter/1999/75047ltr.pdf page 1
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...
Aggrastat (tirofiban HCl Injection premixed)
9123301 AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION PREMIXED) AGGRASTAT ® (TIROFIBAN HYDROCHLORIDE INJECTION) DESCRIPTION AGGRASTAT* (tirofiban hydrochloride), a non- peptide antagonist of the platelet glycoprotein (GP) IIb/ IIIa receptor, inhibits platelet aggregation There were no clinically significant effects of co- administration of these drugs on the...
author: CDER
subject: Label
Aggrastat (tirofiban HCl Injection premixed) page 6
author: CDER
subject: Label
duplicates:http://www.fda.gov/cder/foi/label/1998/20913lbl.pdf
Aggrastat (tirofiban hydrochloride) Injection NDA 20-913
There were no clinically significant effects of co- administration of these drugs on the plasma clearance of tirofiban: acebutolol, acetaminophen, alprazolam, amlodipine, aspirin preparations, atenolol, bromazepam, captopril, diazepam, digoxin, diltiazem, docusate sodium, enalapril, furosemide, glyburide, heparin, insulin, isosorbide, lorazepam, lovastatin, metoclopramide,...
author: CDER
subject: Label
DDPA October 1995
19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE 20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE (TABLET, HYDROCHLORIDE EXTENDED RELEASE) 240MG (ANTIHISTAMINE/DECONGESTANT) (OTC) 20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) (OTC) 20...
DDPA April 1995
19-821 SORIATANE ROCHE ACITRETIN 03-APR-95 (CAPSULE) NUTLEY, NJ 10MG 07110 25MG (RETINOID) [TREATMENT OF SEVERE RECALCITRANT PSORIASIS] 20-325 PEPCID AC MERCK FAMOTIDINE 17-APR-95 (TABLET) WEST POINT, PA 10MG 19486 (HISTAMINE H2- RECEPTOR ANTAGONIST) [PREVENTION AND TREATMENT OF FOOD AND BEVERAGE INDUCED HEARTBURN, ACID INDIGESTION, AND SOUR STOMACH] (OTC) 20-059 ADENOSCAN MEDCO RES...
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 enhance the T1...
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http://www.atsmedical.com/Physicians.aspx?id=1424 Articles and Abstracts For details on the efficacy of cryoablation in the treatment of cardiac arrhythmias consult the clinical articles listed. Heart Lung Circ. J Am Coll Cardiol 2007 Nov 27;50(22):2156-61. Mack CA, et al. Circulation 2004 Aug 31;110(9):1042-6. Ohtsuka T, et al. The Cox Maze III Procedure for Atrial...
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http://www.atsmedical.com/Physicians.aspx?id=1210 Articles and Abstracts For details on the efficacy of cryoablation in the treatment of cardiac arrhythmias consult the clinical articles listed. Heart Lung Circ. J Am Coll Cardiol 2007 Nov 27;50(22):2156-61. Surgical Treatment of Atrial Fibrillation Using Argon-Based Cryoablation During Concomitant Cardiac Procedures.
ATS Medical - Cardiac Ablation Procedure a Atrial Fibrillation
Contact ATS | Search Home A--A- Physicians International A--A- Surgical Ablation A--A-Clinical References Mechanical Valves Product Design Echocardiographic Evaluation FAQs Clinical References Biological Valves Product Design Clinical Summary Clinical References Annuloplasty Products Surgical Tools Surgical Ablation Clinical References Resources Tradeshows/Events Print Page Email...
ATS Medical - Cardiac Ablation Procedure a Atrial Fibrillation
Contact ATS | Search Home A--A- Physicians US A--A- Surgical Ablation A--A-Clinical References Mechanical Valves Product Design Echocardiographic Evaluation FAQs Clinical References Home INR Monitoring Annuloplasty Products Surgical Tools Surgical Ablation Clinical References Resources Tradeshows/Events Print Page Email Page A- Articles and Abstracts For details on the efficacy of...
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...
Index A, 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 - INDEX - Index-A-~ Index-B -~ Index-C -~ Index-D -~ Index-E -~ Index-F -~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M -~ Index-N -~ Index-O ...
Angina: Coronary Artery Disease: Merck Manual Home Edition
Section Heart and Blood Vessel Disorders Subject Coronary Artery Disease Angina Angina, also called angina pectoris, is temporary chest pain or a sensation of pressure that occurs while the heart muscle is not receiving enough oxygen. The kind of pain, its location, and its association with exertion, meals, weather, and other factors help doctors make the diagnosis. Taking...