Last Updated: September 24, 2026

Details for New Drug Application (NDA): 019090

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NDA 019090 describes ZANTAC, which is a drug marketed by Pai Holdings Pharm, Glaxo Grp Ltd, Glaxosmithkline, and Chattem Sanofi, and is included in nine NDAs. Additional details are available on the ZANTAC profile page.

The generic ingredient in ZANTAC is ranitidine hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 019090

Tradename:	ZANTAC
Applicant:	Pai Holdings Pharm
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 19, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 019090

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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