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Documents 1-25 out of 32 found
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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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Development of Generic Drugs: Trade-Name and Generic Drugs: Merck Manual Home Edition
Section Drugs Subject Trade-Name and Generic Drugs Development of Generic Drugs When a company decides to develop a generic version of a trade-name drug, the company's experts in drug formulation figure out how to design it.
For bioequivalence testing, a relatively small number (24 to 36) of healthy volunteers can be used.
However, because inactive ingredients can cause unusual...
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Development of Generic Drugs: Trade-Name and Generic Drugs: 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...
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Sulfonylureas for type 2 diabetes - [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 Sulfonylureas for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Sulfonylureas for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Adult Diabetes, adult onset diabetes, adult onset diabetes mellitus,...
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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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TEXT
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, EPOPROSTENOL SODIUM...

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1997 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
020624 10/11/1997 10/20/1998 Arthrotec (Diclofenac Sodium/Misoprostol) Tablets,- Part 1 , Part 2 ,- Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8 , Part 9 , Part 10 , Part 11 , G.D
Rev.) Part 2B [2.7 MB] (Clin
020280...
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RLD_LABELING_APPROVED_OCT_1999
20-659 S-021 Abbott Labs 21-Oct-1999 ZANTAC INJECTION Ranitidine Injection 19-090 S-040 Glaxo Wellcome 22-Oct-1999 ZANTAC PREMIX IV Ranitidine /Sodium Chloride Injection 19-593 S-030 Glaxo Wellcome 22-Oct-1999 ZANTAC SYRUP Ranitidine Syrup 19-675 S-022 Glaxo Wellcome 22-Oct-1999 ZANTAC EFFERDOSE Ranitidine Effervescent Tablets 20-251 S-008 Glaxo Wellcome 22-Oct-1999 ZANTAC TABLETS...
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Microsoft Word - 75890.ta.doc page 1


author: staufferp
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PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
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Drug Approvals for April 1997
Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX Indication(s)...
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Drug Approvals January 1997
Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
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FDA Drug Approvals List October 1999
Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
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DDPA February 1996
THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
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WORDPERFECT
http://www.fda.gov/cder/da/ddpa93.wpd
03 158 ORETON METHYL SCHERING METHYLTESTOSTERONE 01 07 93 (TABLET) KENILWORTH, NJ 10MG 07033 (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM 01 07 93 (INJECTABLE) PHILADELPHIA, PA EQ 100MG ACID/VIAL 19101 TICARCILLIN DISODIUM EQ 3GM BASE/VIAL (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM 01 07 93 ...

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ehaf020.tmp
CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number : 020051/ S008 Trade Name : GLYNASE PRESTABS Generic Name: Micronized Glyburide 1.5mg, 3mg and 6mg Tablets Sponsor : Pharmacia and Upjohn Company Approval Date: January 10, 1997 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION 020051/ S003 CONTENTS Included Pending Not Not Completion...

author: fda
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ehaf020.tmp page 7


author: fda
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ehaf020.tmp page 1


author: fda
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puva372.tmp page 33


author: fda
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author: fda
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author: fda
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http://www.fda.gov/cder/da/ddpa92.wpd
DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20 051 GLYNASE UPJOHN GLYBURIDE 03 04 92 (TABLET) KALAMAZOO, MI 1.5MG (3 S**) 49001 3MG (BLOOD GLUCOSE REGULATOR) 20 087 FLOXIN...

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Type 2 Diabetes: Recently Diagnosed - Quest Diagnostics Patient Health Library
Medication Choices Medications that increase insulin production Sulfonylureas , such as glipizide (Glucotrol), glyburide (for example, DiaBeta, Glynase, or Micronase), glimepiride (Amaryl), the combination medication glyburide and metformin (Glucovance), and the combination of glipizide and metformin (Metaglip) Meglitinides , such as repaglinide (Prandin) and netaglinide ...
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