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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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Ticlopidine Hydrochloride Tablets Approval Package
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ticlopidine Hydrochloride Tablets 250mg Company:- Purepac Pharmeceutical Co
Application No.:- 75-253 Approval Date:-8/20/99 Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Part 1 - Part 2 - Administrative Document(s) -...
author: USERNAME
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Ticlopidine Hydrochloride Approval Package
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ticlopidine Hydrochloride Tablets 250mg Company:- Invamed Inc
Application No.:- 75-318 Approval Date:-8/20/99 Approval Letter(s) - Printed Labeling - - Chemistry Review(s) - Bioequivalence Review(s) - Part 1 - Part 2 - Correspondence - - Back to Drug Approval Page Some...
author: USERNAME
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75-326_Ticlopidine Hydrochloride
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ticlopidine Hydrochloride Tablets Company:--Eo Labs Manufacturing, Inc
Application No.:--75-326 Approval Date:-8/20/1999 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - Back to Drug...
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 Division of Bioequivalence has determined your Ticlopidine Hydrochloride Tablets, 250 mg, to...
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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
concurrently with the approval of their abbreviated application for Ticlopidine Hydrochloride...
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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
concurrently with the approval of their abbreviated application for ...
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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
concurrently with the approval of their abbreviated application for Ticlopidine Hydrochloride...
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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
concurrently with the approval of their abbreviated application for Ticlopidine ...
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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 Division of Bioequivalence has determined your Ticlopidine ...
author: Unknown
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75089.APF.DOC page 2
author: Unknown
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