http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf Research and devel pment resulted in a rec rd number f new pr duct appr vals that expanded ur fferings in key therapeutic categ ries.
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 16
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Releases 2004 - 2005: Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension Jerusalem, Israel, February 24, 2005 Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease Jerusalem, Israel and Copenhagen, Denmark, February 22, 2005 Teva Announces Settlement Of Lamictal® Litigation...
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel and Tokyo, Japan, May 15, 2003 Teva Announces Approval of Moexipril HCl Tablets Jerusalem, Israel, May 8, 2003 Teva Announces Approval of Megestrol Acetate Oral Suspension Jerusalem, Israel, May 6, 2003 Teva Announces Settlement of Litigation with GSK on Nabumetone Jerusalem, Israel, April 30, 2003 Teva to Report First Quarter 2003 Financial Results on May 1, 2003...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Tentative Approval Of Metformin Hcl Extended Release Tablets, 750 Mg Jerusalem, Israel, December 14, 2004 - Teva Pharmaceutical Industries Ltd.Metformin Hydrochloride Extended Release Tablets, 750 mg.
Drug Approvals - A Activelle (estradiol/norethindrone acetate tablets), 1 mg/0.5 mg, Rx Novo Nordisk Pharmaceuticals NDA 20-907 11/18/98 11/18 11/18 7/8/99 Actonel (risedronate sodium) Tablet, Rx Procter & Gamble Pharmaceuticals NDA 20-835/S14 2/24/04 2/25/04 - - Actonel (risedronate sodium) Tablet, 35 mg, Rx Procter & Gamble Pharmaceuticals NDA 20-835/S8 & S9 5/17/02 5/23/02 - - Actonel (risedronate...
What's new at CDER in the last 30 days Food and Drug Administration • Center for Drug Evaluation and Research What's New by Category Search This page lists new and revised documents posted to the CDER web siteMetformin Hydrochloride Tablets for the treatment of type II diabetes
author: Paul Stauffer
What's new at CDER by Date Patent Term Extension and New Patents Docket Number *95S-0117 (updated) February 19, 2004 Colorectal Cancer Endpoints Workshop Summary FDA approves first-time generic Glyburide and Metformin Hydrochloride Tablets for the treatment of type II diabetesMetformin ...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET,...
Drug Approvals - M ANDA 75-586 5/30/02 - - - Metaproterenol Sulfate Inhalation Solution USP, 0.6%, Rx Novex Pharma ANDA 75-403 2/28/01 3/6/01 - - Metaproterenol Sulfate Inhalation Solution USP, 0.4%, Rx Novex Pharma ANDA 75-402 2/28/01 3/6/01 - - Metaproterenol Sulfate Syrup USP, 10 mg/5 mL, Rx Novex Pharma ANDA 75-235 1/27/00 2/4/00 - - Metaxalone Tablets, 400mg, Rx Tentative Approval CorePharma LLC...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG...
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
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16810 II 20-Aug-2003 ALPHARMA APS "TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK" 16812 II 28-Aug-2003 "CAMBRIDGE MAJOR LABORATORIES, INC." "FP-043 AS MANUFACTURED IN GERMANTOWN, WI." 16813 II 3-Sep-2003 UCB BIOPRODUCTS "DESMOPRESSIN (ACETATE) AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM." 16818 II 26-Aug-2003 KUMAR ORGANIC PRODUCTS LIMITED "TRICLOSAN...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II NOVUS FINE CHEMICALS LLC METFORMIN HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJHYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS...
21-202_Glucophage_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Glucophage XR (Metformin Hydrochloride) Extended Release Tablets Company:--Bristol-Myers Squibb Co
author: USERNAME
20357S019_Glucophage.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Glucophage (Metformin Hydrochloride) Tablets Company:- Bristol-Myers Squibb Application No.:- 20-357/S-019 Approval Date:- - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Statistical Review(s) - Clinical Pharmacology Biopharmaceutics...
author: Paul Stauffer
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25/2002-...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - CREAM; TOPICAL Denied 7/3/2002- LOPERAMIDE HYDROCHLORIDE 1 MG - 02P-0424/CP1 BANNER PHARMACAPS - CAPSULE; ORAL Approved 4/14/2003- LOPERAMIDE HYDROCHLORIDE 2 mg - 02P-0380/CP1 BANNER PHARMACAPS - SOFT GELATIN CAPSULES Pending - MERCAPTOPURINE 100 MG - 00P-1645/CP1 McKENNA & CUNEO - TABLET; ORAL Approved 4/17/2001- METFORMIN HYDROCHLORIDE 1000 MG - 03P-0388...
Alpharma INC. - Alpharma Granted Temporary Restraining Order on Extended Release Metformin Hydrochloride Tablets - Home - News Room - Press release archive - Articles - Alpharma Granted Temporary Restraining Order on Extended Release Metformin Hydrochloride Tablets - - - - - - - - October 30, 2003 ALPHARMA GRANTED TEMPORARY RESTRAINING ORDER ON EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLETS Fort Lee, New Jerseya€¦October 30, 2003a€¦Alpharma Inc
Alpharma INC. - Electronic Investors Kit SEARCH GO
Alpharma INC. - Press release archive SEARCH GO
Tentative Approvals - October 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Tentative Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-048 OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG - TORPHARM 10/6/2003- 2 75-827 GABAPENTIN TABLETS 600 MG AND 800 MG - TEVA PHARMACEUTICALS USA 10/16/2003- 3 76-311 TOPIRAMATE TABLETS 25...
