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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
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Prescription and OTC Drug Product List 6/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN ...
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Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
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Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
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Cholestech - Press Release
thisPage._location = "/company/pr/news.asp"; When you're looking for results.-- Press Release CHOLESTECH ANNOUNCES TWO CONTRACTS TO PROVIDE CHOLESTEROL SCREENING SERVICES FOR SANKYO PHARMA HAYWARD, Calif.
In addition, WellCheck will provide cholesterol testing and information services at three Sankyo-sponsored pilot programs administered at regional educational symposia for the...
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Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library Blood and lymph, Heart and circulation, Heart problems...
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Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library Bile acid sequestrants for high cholesterol - [Medication] - Quest Diagnostics Patient Health Library Blood and lymph, Heart and circulation, Heart problems...
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BioPortfolio Limited
216 Drug overview 216 Clinical trial data 217 Livalo: 12-month event screen 219 Livalo strategic analysis 220 Livalo forecasts to 2011 223 CHAPTER 5 FIBRATES 226 Key findings 226 Overview of the global fibrate market 226 Fibrates market forecast 229 Fibrate brand analysis 232 Lipanthyl and TriCor (fenofibrate) – US generic threat 232 Drug overview 233 Clinical trial data 234...
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Approved Products_2004.xls
Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
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Approved Products_2004.xls page 3
author: Reijer
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Press Releases | News Releases
News Releases Glucowatch® Biographer Reported to Improve Diabetes Control in Children Study published in PEDIATRICS is first ever to demonstrate that monitoring glucose with the Biographer could affect HbA1c levels.
In conjunction with the report, the journal also published a commentary by Leslie P.
Patients were randomized to two groups-one using the Biographer in...
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Press Releases | News Releases
News Releases GlucoWatch® Biographer May Potentially Prevent Numerous Incidences of Severe Diabetic Complications Additional Biographer Data Presented at the American Diabetes Association's Annual Meeting Demonstrates Reading Correlation with Mealtime Blood Glucose Measurements and A1c Parsippany, NJ and Redwood City, CA — June 16, 2003 — Data presented today at the...
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Microsoft Word - Japanese Pharmaceutical Companies Outlook.doc
Reuters Business Insight H E A LT H C A R E The Japanese Pharmaceutical Companies Outlook: An analysis of key players and growth strategies Table of Contents Table of Contents The Japanese Pharmaceutical Companies Outlook: An analysis of key players and growth strategies Executive Summary 12 Introduction 12 Takeda 13 Sankyo 14 Yamanouchi 15 Eisai 16 Fujisawa 17 Daiichi 18 Mitsubishi...
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Microsoft Word - Japanese Pharmaceutical Companies Outlook.doc page 3
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C:\Data\Welchol-N21176\AP.SLR010.doc
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 176/ S- 010 Sankyo Pharma Attention: Jean Lyons Associate Director, Promotion and Advertising 399 Thornall Street, 10 th Floor Edison, NJ 08837 Dear Ms
Lyons: Please refer to your supplemental new drug application dated June 11, 2003, received June 12, 2003,...
author: Valerie Jimenez
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C:\Data\Welchol-N21176\AP.SLR010.doc page 1
author: Valerie Jimenez
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Approved Biotechnology Drugs, 2002
- Treatment of cytomegalovirus retinitis in AIDS patients - Jun 1996 - Visudyne™ (verteporfin for injection) - QLT, Inc., and CIBA Vision - Treatment of wet form of age-related macular degeneration; predominantly classic subfoveal choroidal neovascularization due to pathologic myopia (severe nearsightedness) - Apr 2000 Aug 2001 Vitravene™ (fomivirsen) - Isis...
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Report to the Nation: Drug Review
Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N) Lopinavir/ritonavir...
author: OLIVERN
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NMEs Approved in CY 2000
NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
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DOCUMENT INFORMATION PAGE
NDC 65597- 701- 06 6 TABLETS 625 mg P1702701 Rx only PROFESSIONAL SAMPLE: NOT FOR SALE DOSAGE AND USE: SEE PACKAGE INSERT Each Tablet Contains: Active Ingredient: Colesevelam hydrochloride 625 mg
Store at 25° C (77° F); excursions permitted to 15- 30° C (59- 86° F) [see USP Controlled Room Temperature]
Brief exposure to 40° C does not adversely...
author: JIMENEZV
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DOCUMENT INFORMATION PAGE page 2
author: JIMENEZV
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DOCUMENT INFORMATION PAGE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 176/ S- 008 Sankyo Pharma Inc
Attention: Nashad Islam Associate Director, Regulatory Affairs, CMC 399 Thornall Street, 10 th Floor Edison, NJ 08837 Dear Mr
Islam: Please refer to your supplemental new drug application dated April 14, 2003, received April 15, 2003...
author: JIMENEZV
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DOCUMENT INFORMATION PAGE page 1
author: JIMENEZV
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BIO Editors &Reporters 03LIVE page 68
author: Elinor
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C:\Documents and Settings\kochw\Desktop\NDAs\NDA21176\LTRapS004020\ 703.doc page 1
author: William Koch
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