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Last Updated: April 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017920


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NDA 017920 describes TAGAMET, which is a drug marketed by Glaxosmithkline and Medtech Products and is included in six NDAs. Additional details are available on the TAGAMET profile page.

The generic ingredient in TAGAMET is cimetidine. There are twenty-five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
Summary for 017920
Tradename:TAGAMET
Applicant:Glaxosmithkline
Ingredient:cimetidine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017920

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 14, 1983TE:RLD:No

Expired US Patents for NDA 017920

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-005 Apr 30, 1986   Start Trial   Start Trial
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-004 Dec 14, 1983   Start Trial   Start Trial
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-004 Dec 14, 1983   Start Trial   Start Trial
Glaxosmithkline TAGAMET cimetidine TABLET;ORAL 017920-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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