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 are twenty-five drug master file entries for this compound. One supplier is 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INJECTABLE;INJECTION			Strength	EQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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