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FDA NDA · NDA020745

ZANTAC 75

Sponsor: CHATTEM SANOFI

APPLICATION
NDA020745
TYPE
NDA
ORIGINAL APPROVAL
1998-02-26
LATEST ACTION
1999-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EFFERVESCENT
MARKETING STATUS
Discontinued

Products

ZANTAC 75 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EFFERVESCENT · ORAL

Approval history

1999-03-08Efficacy · Supplement 1 · standardAP
1998-02-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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