Last Updated: September 28, 2026

Details for New Drug Application (NDA): 020745

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NDA 020745 describes ZANTAC 75, which is a drug marketed by Chattem Sanofi and is included in two NDAs. Additional details are available on the ZANTAC 75 profile page.

The generic ingredient in ZANTAC 75 is ranitidine hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 020745

Tradename:	ZANTAC 75
Applicant:	Chattem Sanofi
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EFFERVESCENT;ORAL			Strength	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 26, 1998	TE:		RLD:	Yes

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