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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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19-879S018_Ticlid.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ticlid (Ticlopidine Hydrochloride) Tablets Company:--Syntex (U.S.A.) LLC Application No.:--19-979/S-018 Approval Date:-4/18/01 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Statistical Review(s) Administrative Document(s) -...
author: Paul Stauffer
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http://www.fda.gov/cder/foi/appletter/2000/75309ltr.pdf
Ebo Drive South Brewster, NY 10509 Dear Madam: This is in reference to your abbreviated new drug application dated January 13, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid Tablets of Syntex U
The...
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http://www.fda.gov/cder/foi/appletter/2000/75309ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/2000/75309ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/1999/75316ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/1999/75316ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/1999/74994TA.PDF page 1
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http://www.fda.gov/cder/foi/appletter/1999/75149ltr.pdf
Jaskot 1510 Delp Drive Kulpsville, PA 19443 Dear Madam: This is in reference to your abbreviated new drug application dated June 20, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid Tablets of Syntex U
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http://www.fda.gov/cder/foi/appletter/1999/75149ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/1999/75149ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/1999/75253ltr.pdf
Attention: Joan Janulis 200 Elmora Avenue Elizabeth, NJ 07207 Dear Madam: This is in reference to your abbreviated new drug application dated November 14, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid...
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http://www.fda.gov/cder/foi/appletter/1999/75253ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/1999/75253ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/1999/75318ltr.pdf
2400 Route 130 N Dayton, NJ 08810 Dear Sir: This is in reference to your abbreviated new drug application dated January 21, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid Tablets of Syntex U
concurrently...
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http://www.fda.gov/cder/foi/appletter/1999/75318ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/1999/75318ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/1999/75326ltr.pdf
Ciganek 227- 15 North Conduit Avenue Laurelton, NY 11413 Dear Madam: This is in reference to your abbreviated new drug application dated January 30, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid Tablets of...
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http://www.fda.gov/cder/foi/appletter/1999/75326ltr.pdf page 2
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http://www.fda.gov/cder/foi/appletter/1999/75326ltr.pdf page 1
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75089.APF.DOC
Agent for: TorPharm 50 Lakeview Parkway, Suite 127 Vernon Hills, IL 60061 Dear Madam: This is in reference to your abbreviated new drug application dated March 3, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Ticlopidine Hydrochloride Tablets, 250 mg
The listed drug product (RLD) referenced in your application, Ticlid...
author: Unknown
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75089.APF.DOC page 1
author: Unknown
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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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Angina: Coronary Artery Disease: 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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