Last Updated: September 24, 2026

Details for New Drug Application (NDA): 019434

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NDA 019434 describes TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cimetidine hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 019434

Tradename:	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Glaxosmithkline
Ingredient:	cimetidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 019434

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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