http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Our largest selling product, Tamoxifen Citrate, the breast cancer treatment we distribute, continued to enjoy both sales and volume growth.Tamoxifen sales to total product sales, higher marg i n s e a rned on Tamoxifen due to a price increase which...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 40
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 4
Pages Sales of Tamoxifen, the breast cancer treatment previously distributed and now manufactured by Barr, decreased significantly as expected, following the February 2003 introduction of our manufactured product, along with products from other generic competitors.
author: Lisa
Pages page 16
author: Lisa
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Final Approval of Tamoxifen Citrate Tablets Jerusalem, Israel, February 21, 2003 - Teva Pharmaceutical Industries Ltd.Tamoxifen Citrate Tablets USP, 10 mg and 20 mg.Tamoxifen Citrate Tablets are the AB-rated generic...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Pharmaceutical Industries Ltd Receives Final FDA Approval of Tamoxifen Citrate 10 mg Jerusalem, Israel, June 1, 2000 - Teva Pharmaceutical Industries Ltd.Tamoxifen Citrate 10mg...
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 Releases Israel Makov Appointed COO Jerusalem, December 29, 2000 Teva Launches Copaxone® in the U.K.
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Custom Pellets Published by Cemagref: 389-400 (1991) MANUMYCIN: Journal of Clinical Endocrinology & Metabolism, 86(4): 1769-1777 (2001) 1-METHYL-DL-TRYPTOPHAN: Nature Immunology 2(1):64-68 (2001) Science, 281: 1191-1193 (1998) Nature Immunology, Advance Online Publication, September 30, 2002 NANDROLONE DECANOATE: Journal of Applied Physiology, 63(5): 2122-2127 (1987) Journal of Applied Physiology,...
New Topics Diagnostic Imaging Computer-Aided Detection in Screening Mammography (October 2002) Doppler Flow Testing of Vascular Access Grafts (October 1998) FDG SPECT for Diagnosing Ischemic Heart Disease (January 1998) Helical CT for Detection of Lung Cancer (April 2002) Magnetic Resonance Imaging for Diagnosis of Breast Cancer (May 2001) PET for Diagnosis of Alzheimer's Disease (November 2002...
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 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies Pharmaceutical Division DDMAC 5/6 5/29 Actiq (Oral Transmucosal Fentanyl Citrate) Anesta DDMAC 5/27 6/3 Aggrastat (Tirofiban HCl) Injection and Injection, Premixed Merck DDMAC 5/11 5/29 Alprox-TD (Alprostadil) NexMed DDMAC 5/26 6 Avapro (irbesartan) Tablets Bristol-Myers Squibb DDMAC 5/28 6/5 Detrol (tolterodine tatrate) Tablets Pharmacia and Upjohn DDMAC 5/29 4/9 Dovonex ...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 5/21/99 6/1/99 June Agenerase (amprenavir) Glaxo Wellcome DDMAC 6/4/99 6/9/99 Avandia (rosiglitazone maleate) tablets SmithKline Beecham DDMAC 6/29/99 7/1/99 Lipitor (atrovastatin calcium) tablets Parke-Davis DDMAC 6/22/99 6/29/99 Navelbine (vinorelbine) for injection Glaxo Wellcome DDMAC 6/21/99 8/6/99 Site Inspection-Warning Letter Solvay Pharmaceuticals DMPQ 6/23/99 7/2/99...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt FACILITIES" 5202 03-Jan-84 PHARMACIA AND UPJOHN INC "DINOPROSTONE SYNTHETIC (BULK) MFG KALAMAZOO, MI FACILITIES (PORTAGE RD" 5204 22-Dec-83 LUDWIG HEUMANN AND CO GMBH TAMOXIFEN CITRATE 5208 09-Jan-84 FABBRICA ITALIANA SINTETICI "OXAZEPAM,BULK FORM AS PRODUCED IN THE VICENZA FACILITIES" 5223 16-Dec-83 FABBRICA ITALIANI SINTETICI SPA "TEMAZEPAM, BULK FORM" 5238 16-Feb-84...
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Drug Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Nolvadex (Tamoxifen Citrate) Tablets Company:--AstraZeneca Pharmaceuticals Application No.:--17-970/S49 FA & S51 Approval Date:-1/30/03 Approval Letter(s) - Printed Labeling - Medical Review(s) - Administrative Document(s) - - Back to Drug Approval Page Some documents are...
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17-970S046_Nolvadex.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Nolvadex (Tamoxifen Citrate) Company:--AstraZeneca Pharmaceuticals Application No.:--17-970/S-046 Approval Date:-6/29/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) - Clinical Pharmacology...
author: Paul Stauffer
../2002/21109_Nolvadex_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Nolvadex (Tamoxifen Citrate) Tablets Company:--AstraZeneca Pharmaceuticals, LP Application No.:--21-109 Approval Date:-8/30/02 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) - Clinical...
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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, 2003 APR...
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OGD, First Time Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs Approved Drugs First Time Generic May 2000 - Established Name/Dosage Form and AP Date SOTALOL HYDROCHLORIDE TABLETS 80 MG 120 MG 160 MG 240 MG 5/1/00 NABUMETONE TABLETS 500 MG 5/26/00 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) 5/31/00 - Back to Top ...
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ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1
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OGD, Tentative Approvals June 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs ANDAs Tentative Approvals June 2000 1TAMOXIFEN CITRATE NOVOPHARM LIMITED 6/28...
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