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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...
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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,...
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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
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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
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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...
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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 P
Box 1090 North Wales, PA 19454 Dear Sir: This is in reference to your abbreviated new drug application dated August 13, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Bisoprolol Fumarate and Hydrochlorothiazide...
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http://www.fda.gov/cder/foi/appletter/2001/75686ltr.pdf page 1
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Prescription and OTC Drug Product List 9/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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http://www.fda.gov/cder/foi/appletter/2000/75642ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/2000/75768ltr.pdf
ANDA 75- 768 September 25, 2000 Mylan Pharmaceuticals, Inc
Box 4310 Morgantown, WV 26504- 4310 Dear Sir: This is in reference to your abbreviated new drug application dated December 23, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/ 6.25 mg, 5 mg/ 6.25...
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http://www.fda.gov/cder/foi/appletter/2000/75768ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/2000/75579ta.pdf
ANDA 75- 579 March 2, 2000 Eon Labs Manufacturing, Inc
Ciganek 227- 15 North Conduit Avenue Laurelton, NY 11413 Dear Madam: This is in reference to your abbreviated new drug application dated February 4, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/ 6...
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http://www.fda.gov/cder/foi/appletter/2000/75579ta.pdf page 1
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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 ...
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DDPA April 1996
***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134 60MG...
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http://www.fda.gov/cder/da/ddpa93.wpd
DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 18 936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE 12-23-92 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE (SUPPL) 46285 (NEW STRENGTH) 19 627 DIPRIVAN...
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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 ...
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C:\Data\labeling\20186_s015_19982_s010_ap.doc page 1
author: Melissa Robb
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Drug Approvals - B
ANDA: 75-768 9/25/00 11/7/00 - - Bisoprolol 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, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Purepac Pharmaceutical Co
ANDA: 75-672 9/25/00 11/7...
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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
(GATIFLOXACIN), MANUFACTURED IN NORTH CHICAGO, ILLINOIS" 13906 22-Dec-98 BIONEBRASKA INC "RECOMBINANT GLUCAGON-LIKE PEPTIDE-1 (RGLP), MANUFACTURED IN LINCOLN, NEBRASKA" 13907 17-Dec-98 MULTIPLE PEPTIDE SYSTEMS "SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76, MPS-77, AND MPS-78,...
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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 - 1
75-396 MIDAZOLAM HYDROCHLORIDE FAULDING PHARMACEUTICAL 5/5/00 INJECTION 1 MG (BASE)/ML 5 CO
MG (BASE)/ML 2
75-672 BISOPROLOL FUMARATE AND PUREPAC PHARMACEUTICAL 5/11/00 HYDROCHLOROTHIAZIDE CO
author: USERNAME
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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
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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
75-412 TIMOLOL MALEATE NOVEX PHARMA 9/8/00 OPHTHALMIC SOLUTION, USP 0.5% (BASE) 4
75-287 PEMOLINE TABLETS 37.5 MG 75 WATSON LABORATOTIES, INC
40-397 CARISOPRODOL TABLETS, USP COREPHARMA...
author: USERNAME
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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...
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