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 Zelnorm ...
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...
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 8/1/2001...
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,...
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
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 Pharmacology...
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
OGD, Tentative Approvals May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs ANDAs Tentative Approvals May 2000 - 1BISOPROLOL FUMARATE AND PUREPAC PHARMACEUTICAL 5/11/00 HYDROCHLOROTHIAZIDE CO
author: USERNAME
OGD, First Time Approvals - September 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs Approved Drugs Log - First Time Generic - September 2000 Established Name/Dosage Form and AP Date PACLITAXEL INJECTION 6 MG/ML 9/15/00 AMOXICILLIN TABLETS, USP 500 MG 875 MG 9/18/00 DACARBAZINE FOR INJECTION, USP 500 MG (SINGLE-DOSE VIAL) (ADDITIONAL ST 9/22/00 ...
author: USERNAME
ANDAs Approvals - September 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals- September 2000 Page: 1 Friday, October 06, 2000 1
author: USERNAME
OGD, First Time Approvals - November 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs Approved Drugs Log - First Time -November 2000 ANDA No Established Name/Dosage Form and Applicant SUB Date TA Date AP Date 74-713 CISPLATIN FOR INJECTION USP, - 10 MG/VIAL, BEDFORD LABORATORIES 8/18/95 11/14/00 50 MG/VIAL 75-643 BISOPROLOL FUMARATE ...
author: USERNAME
ANDAs Approvals - November 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals-November 2000 Page: 1 1
author: USERNAME
ANDA Drug Approvals - October 2002 -U.S
author: OGD
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...
ANDA Approvals June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals - June 2001 - ANDA Number Drug Name Applicant Approval Date 1 40-374 TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.025% THAMES PHARMACAL CO., INC
author: USERNAME
FDA Drug Approvals List June 2001 Application #: 020702 Efficacy Supplement#: 025 Type: SE8 to Original New Drug Application Approval Date: 08-JUN-01 Trade Name: LIPITOR Dosage Form: TABLET Applicant: PFIZER IRELAND PHARMACEUTICALS Active Ingredient(s): ATORVASTATIN CALCIUM OTC/RX Status: RX Efficacy Claim: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
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
http://www.tanabe.co.jp/english/ir/reports/e-result2002.pdf Financial Results for Year Ended March 2002 Tanabe Seiyaku Co., Ltd. 1 Consolidated Financial Results for Year Ended March 2002 <Supplement> As of March 31, 2002 TANABE SEIYAKU CO., LTD. The figures for these unaudited financial statements which are on English translation of the Supplement of Consolidated ...
http://www.tanabe.co.jp/english/ir/reports/e-result2002.pdf page 10 Financial Results for Year Ended March 2002 Tanabe Seiyaku Co., Ltd. 10 Tanabe's R& D Pipeline As of May 17, 2002 Stage Product (R& D Code) Generic Name Category (Indication) Origin Development In Preparation for Launch Remicade (TA- 650) Infliximab Anti- TNF alpha chimeric monoclonal antibody ...
duplicates:http://www.tanabe.co.jp/english/ir/pdf/e-result2002.pdf
http://www.fda.gov/cder/foi/appletter/2001/75686ltr.pdf ANDA 75- 686 January 19, 2001 Teva Pharmaceuticals USA Attention: Philip Erickson 1090 Horsham Road PBisoprolol Fumarate and Hydrochlorothiazide...
http://www.fda.gov/cder/foi/appletter/2001/75686ltr.pdf page 1
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
