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Last Updated: June 25, 2021

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Details for New Drug Application (NDA): 017924


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NDA 017924 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 017924
Tradename:TAGAMET
Applicant:Glaxosmithkline
Ingredient:cimetidine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Expired US Patents for NDA 017924

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TAGAMET cimetidine hydrochloride SOLUTION;ORAL 017924-001 Approved Prior to Jan 1, 1982   Get Started Free   Get Started Free
Glaxosmithkline TAGAMET cimetidine hydrochloride SOLUTION;ORAL 017924-001 Approved Prior to Jan 1, 1982   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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