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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
NDA 5-619/S-016 3/30/01 5/16/02 - - Aminosyn, 5%, 7%, 8.5%, 8.5% w/Electrolytes & 10%, Rx Abbott Laboratories NDA 17-673/S-065 17-789/S-051 6/12/03 7/8/03...
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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,...
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../2001/50781_Arestin_
Food and Drug Administration • Center for Drug Evaluation and Research Title Search Arestin (Minocycline Hydrochloride) Microspheres Company:--OraPharma, Inc
Application No.:--50-781 Approval Date:-2/16/01 Approval Letter(s) - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) - Microbiology Review(s) -- Clinical...
author: USERNAME
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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
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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...
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Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
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Antibiotics/antimicrobials for gum disease - [Medication] - Quest Diagnostics Patient Health Library
Antibiotics/antimicrobials for gum disease Examples Brand Name Chemical Name - penicillin - clindamycin - metronidazole Peridex, Periogard chlorhexidine gluconate Periostat doxycycline hyclate Colgate Total toothpaste triclosan Atridox doxycycline hyclate PerioChip chlorhexidine gluconate Arestin minocycline Sustained-release antibiotics Brand Name Chemical Name Atridox...
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Orapharma | Pressroom | Press Releases
Press Releases Fact Sheet November 13, 2002 Johnson & Johnson to Acquire OraPharma, Inc.
Arestin™, OraPharma's initial product, is a locally delivered antibiotic (Minocycline Microspheres), which is administered to patients with periodontitis.
The results infer that secondary infections such as periodontal disease may be a trigger factor for such diseases and therefore...
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Approved Products_2004.xls
Of E pivir, Retrovir, Ziagen HIV infection BioChem Pharma LIST OF APPROVED BIOTECHNOLOBY PRODUCTS (Page 4: product 151- 200) Number Approval Date Trade Name Generic/ Chemical name Indication Company 151 Dec- 00 Angiomax Bivalirudin Unstable Angina The Medicines Company 152 Dec- 00 Tamiflu Oseltamivir phosphate Liquid suspension for children ages 1- 12 Gilead Sciences 153 Dec- 00 M...
author: Reijer
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Approved Products_2004.xls page 4
author: Reijer
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http://www.fda.gov/cder/foi/label/2001/50781lbl.pdf
Clinical Trials Study OPI- 103A N= 368 Study OPI- 103B N= 380 Time S/ RP Alone N= 124 S/ RP + Vehicle N= 123 S/ RP + ARESTIN N= 121 S/ RP Alone N= 126 S/ RP + Vehicle N= 126 S/ RP + ARESTIN N= 128 PD (mm) at Baseline, mean ± SE 5.88 ± 0.04 5.91 ± 0.04 5.88 ± 0.04 5.79 ± 0.03 5.82 ± 0.04 5.81 ± 0.04 PD (mm) Change from Baseline at 9...
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http://www.fda.gov/cder/foi/label/2001/50781lbl.pdf page 5
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http://www.fda.gov/cder/foi/label/2001/50781lbl.pdf page 1
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December 17, 2001 page 17
author: BioCentury Publications Inc.
subject: BioCentury
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Barr Laboratories, Inc.
This case involves raw material patents.
Downey Chairman 6 This year, we will add the challenge of integrating our Company with Duramed to the commitments that I am asking our employees to make.
Two other products in our oral contraceptive pipeline involve patent challenges.
In January 2001, we received approval for Amiodarone Hydrochloride,...
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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...
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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...
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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,...
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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...
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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
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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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 ...
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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...
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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
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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
Application No.:-ANDA 63-065- Approval Date:-12/30/91 Approval Letter(s) - Printed Labeling Chemistry Review(s) -- Bioequivalence Review(s) - Administrative Document(s) - Correspondence - - Back to Drug...
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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
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