Details for New Drug Application (NDA): 019675

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NDA 019675 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 019675

Tradename:	ZANTAC
Applicant:	Glaxo Grp Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 15MG BASE/ML
Approval Date:	Dec 30, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019675

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	4,128,658	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	5,068,249*PED	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	4,585,790*PED	⤷ Subscribe
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	4,521,431*PED	⤷ Subscribe
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