Details for New Drug Application (NDA): 021698

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NDA 021698 describes ZANTAC 150, which is a drug marketed by Glaxosmithkline, Glaxo Grp Ltd, and Chattem Sanofi, and is included in four NDAs. Additional details are available on the ZANTAC 150 profile page.

The generic ingredient in ZANTAC 150 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 021698

Tradename:	ZANTAC 150
Applicant:	Chattem Sanofi
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 31, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 13, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021698

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-002	Mar 13, 2007	5,098,715	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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