http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Hydrochloride, ...
BioPortfolio Limited World Neurodegeneratives Disease Markets, 2005-2009 1.Introducing the World Market for Neurodegenerative Disorders Table 1.1 Overall Forecast for Neurodegenerative Market ($bn), 2002 - 2009 Graph 1.1 Total revenues for Neurodegenerative diseases ($bn) 2002 - 2009 Graph 1.2 Annual Growth Rate for ND Market 2002 - 2009 Chart 1.1 The Market Share (%) for ND diseases 2003 Chart 1.2...
IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
Drug Approvals - A 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
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 NDA 17-442/S-029 6/12/01 11/25/02 Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Rx Wyeth-Ayerst Research NDA 50-649/S5 & S7 2/1/02 4/17/02 - - Minocin (minocycline hydrochloride) Intravenous, Oral Suspension & Pellet-Filled Capsules, Rx Wyeth Pharmaceuticals NDA 50-444/S36, 50-445/S19 & 50649S11 5/31/02 6/3/02 - - Minocin (minocycline hydrochloride) Oral Suspension, Rx...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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 OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD ...
../2001/50781_Arestin_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Arestin (Minocycline Hydrochloride) Microspheres Company:--OraPharma, Inc
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - Minocycline Hydrochloride Capsules- Company:--Danbury Pharmacal, Inc
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
author: AUTHOR
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Minocycline Hydrochloride Capsules- Company:--Danbury Pharmacal, Inc
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 1HYDROCHLORIDE INJECTION 1 MG (BASE)/ML, -- 5 MG (BASE)/ML 2HYDROCHLORIDE IMPAX LABORATORIES, INC
author: USERNAME
65-005_Minocycline Hydrochloride Capsules USP Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Minocycline Hydrochloride Capsules USP Company:--Global Pharmaceutical Corporation Application No.:--65-005 Approval Date:-3/23/1999 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - Back...
author: Paul Stauffer
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
First-Time Generics - April 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - April 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) ANDRX PHARMACEUTICALS, L.L.P
author: OGD
ANDA Approvals April 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - April 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-391 ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE) NOVEX PHARMA 4/1/2003- 2 76-371 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) BARR LABORATORIES, INC
author: OGD
NDA Approvals for Calendar Year 2001 NDA APPROVALS FOR CALENDAR YEAR 2001 Updated through December 31, 2001 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21-252 Canasa Mesalamine Axcan Scandipharm 5 P 05-Jan-01 21-208 Remeron SolTab Mirtazapine Organon 3 S 12-Jan-01 21-227 Cancidas Caspofungin Acetate Merck Research Labs 1 P 26-Jan-01 21-261 Monistat 3 Combination...
author: Brenda Harmon
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
FDA Drug Approvals List February 2001 - Drug Approvals for February 2001 Definitions and Notes Original New Drug Applications Original Application #: 021169 Approval Date: 28-FEB-01 Trade Name: REMINYL Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate dementia...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02...
