Last Updated: September 24, 2026

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 two 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:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 300MG BASE/2ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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, 1982	TE:		RLD:	No

Expired US Patents for NDA 017939

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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	3,950,333	⤷ Start Trial
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	4,024,271	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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