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Last Updated: November 15, 2024

Details for New Drug Application (NDA): 017939


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NDA 017939 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. Eighteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.
Summary for 017939
Tradename:TAGAMET
Applicant:Glaxosmithkline
Ingredient:cimetidine hydrochloride
Patents:0

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 017939

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TAGAMET cimetidine hydrochloride INJECTABLE;INJECTION 017939-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline TAGAMET cimetidine hydrochloride INJECTABLE;INJECTION 017939-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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