http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf Research and devel pment resulted in a rec rd number f new pr duct appr vals that expanded ur fferings in key therapeutic categ ries.
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 16
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,...
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 RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN...
21-202_Glucophage_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Glucophage XR (Metformin Hydrochloride) Extended Release Tablets Company:--Bristol-Myers Squibb Co
author: USERNAME
20357S019_Glucophage.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Glucophage (Metformin Hydrochloride) Tablets Company:- Bristol-Myers Squibb Application No.:- 20-357/S-019 Approval Date:- - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Statistical Review(s) - Clinical Pharmacology...
author: Paul Stauffer
Alpharma INC. - Alpharma Granted Temporary Restraining Order on Extended Release Metformin Hydrochloride Tablets - Home - News Room - Press release archive - Articles - Alpharma Granted Temporary Restraining Order on Extended Release Metformin Hydrochloride Tablets - - - - - - - - October 30, 2003 ALPHARMA GRANTED TEMPORARY RESTRAINING ORDER ON EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLETS Fort Lee, New Jerseya€¦October 30, 2003a€¦Alpharma Inc
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
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
First-Time Generics - January 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - January 2002 Generic Name Brand Name Approval Date 1 SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MG AZULFIDINE EN-TABS 1/11/02 2 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS) FLOXIN I.VMETFORMIN HYDROCHLORIDE TABLETS...
author: USERNAME
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
FDA Drug Approvals List January 2002 Active Ingredient(s):LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076119 Tentative Approval Date: 15-JAN-02 Trade Name: MIRTAZAPINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Original Abbreviated Application #: 075977 Tentative Approval Date: 15-JAN-02 Trade Name: TRAMADOL HYDROCHLORIDE ...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
DOCUMENT INFORMATION PAGE The structural formula is as shown: ° HCl Metformin Hydrochloride H3C N H N NH2 CH3 NH NH METAGLIP is available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride
author: James Cross
C:\Data\My Documents\NDA\N21410AP5.doc Special Populations Renal Impairment: In subjects with decreased renal function (based on measured creatinine clearance), the plasma and blood half- life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance (see WARNINGS, also see GLUCOPHAGE 1 prescribing information, CLINICAL PHARMACOLOGY, Pharmacokinetics)...
author: Jena Weber
Prescription and OTC Drug Product List 11/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
FDA Drug Approvals List- October 1998 Drug Approvals for October 1998 Definitions and Notes October 1998 Original New Drug Applications Original Application #: 020926 Approval Date: 30-OCT-98 Trade Name: RENAGEL Chemical Type: 1 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: GELTEX PHARMACEUTICALS INC Active Ingredient(s): SEVELAMER HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the reduction of serum...
Drug and Device Approvals March 1995 74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to enhance the T1...
Novo Nordisk A/S - Lars Rebien SA¸rensen, Health Care CONTACT US SITEMAP SEARCH Diabetes-care Biopharmaceuticals About-us R&D; Media Investors Sustainability Jobs News Novo Nordisk in short Calendar Download centre Conference calls Corporate Governance IR guidelines IR Contacts R&D; pipeline Share information Sustainability Subscription Annual Report 2004 FAQ Lars Rebien SA¸rensen, Health Care Before I address the important issues...
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...
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...
Obesity: Problems in Adolescents: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
