← FDA DRUG APPROVALS

FDA NDA · NDA020520

ZANTAC 75

Sponsor: CHATTEM SANOFI

APPLICATION
NDA020520
TYPE
NDA
ORIGINAL APPROVAL
1995-12-19
LATEST ACTION
2019-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZANTAC 75 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL

Approval history

2019-09-18Labeling · Supplement 38 · standard — Letter ↗AP
2019-04-04Labeling · Supplement 37 · standard — Letter ↗AP
2016-07-27Labeling · Supplement 33 · standard — Label ↗AP
2016-01-26Labeling · Supplement 32 · standard — Letter ↗AP
2015-11-20Labeling · Supplement 30 · standard — Label ↗AP
2015-09-24Manufacturing (CMC) · Supplement 31 · standardAP
2015-01-30Labeling · Supplement 28 · standard — Letter ↗AP
2013-07-25Manufacturing (CMC) · Supplement 26 · standardAP
2005-02-28Labeling · Supplement 15 · standard — Review ↗AP
2002-12-03Manufacturing (CMC) · Supplement 13 · standardAP
2002-05-30Manufacturing (CMC) · Supplement 12 · standardAP
2001-05-29Labeling · Supplement 10 · standardAP
2000-11-08Manufacturing (CMC) · Supplement 9 · standardAP
2000-06-07Manufacturing (CMC) · Supplement 8 · standardAP
2000-02-28Manufacturing (CMC) · Supplement 6 · standardAP
1998-06-08Efficacy · Supplement 1 · unknown — Review ↗AP
1998-05-22Manufacturing (CMC) · Supplement 3 · standardAP
1998-04-01Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-08Manufacturing (CMC) · Supplement 4 · standardAP
1997-03-26Manufacturing (CMC) · Supplement 2 · standardAP
1995-12-19Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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