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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Barr Laboratories, Inc.
In May 2001, we filed an application for Flecainide Acetate tablets, a cardiovascular product, which is sold under the brand name Tambocor TM.
CyPat Clinical Study Cyproterone Acetate, which we intend to market in the United States under the name CyPat, is a steroid that blocks the action of testosterone.
In February 2000, we filed an...
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 15
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Pages
Additional Patent Challenges During fiscal 2003, we announced five additional patent challenges, including challenges for: Eli Lilly's Evista® product for the treatment and prevention of osteoporosis in postmenopausal women; Kos Pharmaceutical's Niaspan® 500 mg and 750 mg extended release tablets for cholesterol; Ferring's patent related to DDAVP® (Desmopressin ...
author: Lisa
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Products: listing products
site map privacy policy disclaimer - Browse Our Product Types - Search Our Products - Browse Our Categories Products: listing products Category NEW PRODUCTS [NEW] 357 "NEW PRODUCTS" found NEW PRODUCTS Name Isotope Qty Price "CELL FREE" AMINO ACID MIX (U-13C, 98%; U-D, 98%; U-15N, 98%) 0.5G $2,500.00 "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%) G Please Inquire "CELL FREE" AMINO ACID...
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Products: listing products
>> NEW PRODUCTS -- - Name Isotope Qty Price NEW PRODUCTS [ top ] "CELL FREE" AMINO ACID MIX (U-13C, 98%; U-D, 98%; U-15N, 98%) 0.5G $2,500.00 "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%) G Please Inquire "CELL FREE" AMINO ACID MIX (20AA) (U-D, 98%; U-15N, 98%) G Please Inquire 0.1% METHANOL-13C + 0.3 MG/ML GDCL3 IN 98.9% D2O + 1% H2O 1 5MM TUBE $110.00 0.1MG/ML GDCL3 +0.1 % DSS 20%...
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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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Miscellaneous
(PLEASE INQUIRE) 2-ACETAMIDOFLUORENE (2-AAF) A-102 A-21 SA-102 A-60 NA-102 A-90 9,10-DIMETHYL-1,2-BENZANTHRACENE D-117 A-21 SD-117 A-60 ND-117 A-90 ALLOXAN A-103 A-21 SA-103 A-60 NA-103 A-90 ALTHIAZIDE A-104 B-21 SA-104 B-60 NA-104 B-90 AMINOACETONITRILE A-105 B-21 SA-105 B-60 NA-105 B-90 AMINOPYRINE A-109 B-21 SA-109 B-60 NA-109 B-90 BACLOFEN B-110 A-21 SB-110 A-60 NB-110 A-90...
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Pellets for Immuno
278J Progress in Cancer Research & Therapy, 35:430-435 1988 - - Testosterone, 5α -Dihydrotestosterone, Flutamide and Cyproterone Acetate Pellets for Tumor Growth and Regression in Immuno-Deficient Mice - It has been established that the growth and regression of androgen-dependent tumor tissue in mice is dependent upon three factors: 1.
The most commonly used 60-day and...
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Drug Approvals - D
Desferal (deferoxamine mesylate, USP) Injection,- Novartis Pharmaceutical Company NDA 16-267/S-039 2/14/02 3/8/02 Desferal (deferoxamine mesylate, USP) Injection,- Novartis Pharmaceutical Company NDA 16-267/S-034 4/9/01 10/16/02 - - Desmopressin Acetate Injection,4 mcg/mL (packaged in 1 mL ampules), Rx Abbott Laboratories ANDA 75-220 8/28/00 10/31/00 - - Desmopressin Acetate...
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Drug Approvals - A
NDA 9-048/S-037 3/26/03 4/15/03 4/1/03 (17-beta-estradiol transdermal), patch 3 sizes 13.5, 20, and 27cm2, with normal delivery of.05,.075 and 0.1mg per day for 7 days., Rx Trade name not established Wyeth-Ayerst NDA 21-048 9/20/99 9/24/99 9/24/99 - - 17-beta-estradiol transdermal Indication: Treatment of vulvar vaginal atrophy and vasomotor symptoms Abilify (aripiprazole...
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Prescription and Over-the-Counter Drug Product List: 1/2004
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >D> AB EQ 8MG BASE...
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Drug Approvals - M
NDA 16-979/S-051 8/27/02 8/30/02 Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Roxane Laboratories, Inc
ANDA 75-997 2/15/02 - - - Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Copley Pharmaceutical ANDA 75-681 5/5/03 - - - Megestrol Acetate Oral Suspension, 40 mg/mL., Rx Par Pharmaceutical, Inc
ANDA 75-671 7/2 5/01 - -1/17/02 - -1/17/02 Megestrol ...
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Drug Approvals - N
ANDA 40-455 3/3/03 Norethindrone Acetate Tablets USP, 5 mg, Rx Barr Laboratories, Inc
NDA 13-416/S21 11/25/02 12/6/02 11/26/02 Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg, packaged in 28-day cycle regimens, Rx Tentatively Approved 1/6/2004 - Andrx Pharmaceuticals ANDA 76-335 1/6/04 Norgestrel and Ethinyl ...
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1996 and Older - New Drug Application (NDA)
18891-S15 9/6/96 8/5/2003 Cefotan/cefotetan disodium injection [1.8 MB] Zeneca Pharmaceuticals 50694 7/30/1993 3/4/1999 Cerebyx Injection Parke Davis 020450/S1 12/26/1996 6/17/2003 Claritin Tablets Schering 19658/S005 2/15/94 5/25/01 Climara (estradiol transdermal system) 3M Pharmaceuticals 20375 - S5 05/17/1996 8/11/2003 Climara (estradiol transdermal system) 3M...
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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...
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Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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http://www.fda.gov/cder/orange/appendix_a.txt
IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
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EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003
CASPOFUNGIN ACETATE MERCK RES 21-227 SE1 007 7-Mar-02 7-Jan-03 10.1 Provides for the use of Cancidas (caspofungin acetate) For Injection for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
CONJUGATED ESTROGENS / MEDROXYPROGESTERONE ACETATE WYETH AYERST 20-527 SE2 017 15-Jun-00 12-Mar...
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C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc
The structural formulas are as follows: OH CH 3 O H H C CH H H Ethinyl Estradiol Molecular Weight: 296.41 Molecular Formula: C20H24O2 Revised January 5, 2004 2 O CH 3 O H CCH 3 O H C CH H H Norethindrone Acetate Molecular Weight: 340.47 Molecular Formula: C22H28O3 CLINICAL PHARMACOLOGY Estrogens are largely responsible for the development and maintenance of the female...
author: Bronwyn Collier
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C:\Data\My Documents\drugs\estrogen\WHI labeling supps\femhrt\AP \ 21065 S-009.doc page 2
author: Bronwyn Collier
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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
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
IN LAFAYETTE, INDIANA" 4676 27-Sep-82 BASF AKTIENGESELLSCHAFT 13-CIS-RETINOIC ACID (ISOTRETINOIN) 4684 13-Oct-82 SCHERING AG "ESTRADIOL MANUFACTURED IN BERLIN, GERMANY." 4687 14-Oct-82 SUMIKA FINE CHEMICALS CO LTD DISOPYRAMIDE PHOSPHATE USP XX 4688 16-Oct-82 KONGO CHEMICAL CO LTD DEXCHLORPHENIRAMINE MALEATE 4690 13-Oct-82 SCHERING AG ESTRADIOL-3-BENZOATE 4691 19-Oct-82...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE ...
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21-276_Estrostep.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Estrostep Fe (Norethindrone Acetate, 1mg & Ethinyl Estradiol, 35mcg) Tablets Company:--Parke-Davis Pharmaceutical Research Application No.:--21-276 Approval Date:-7/13/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 Part 2 Part 3 - Chemistry Review(s...
author: Paul Stauffer
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OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET; DELAYED-RELEASE, ORAL Approved 4/18/2000- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- CLOZAPINE 12.5 MG - 99P-1267/CP1 LACHMAN CONSULTANT SERVICES - TABLET;ORAL Approved 2/17/2000- CLOZAPI NE 200 MG - 99P-1268/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 2/17/2000- METHYLPHENIDATE...
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