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Last Updated: March 19, 2026

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. Seventeen 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 300MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 017924

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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	3,950,333	⤷ Get Started Free
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982	4,024,271	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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