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 are forty-three drug master file entries for this compound. Twelve 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
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	⤷ Sign Up	⤷ Sign Up
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Sign Up	⤷ Sign Up
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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