← FDA DRUG APPROVALS

FDA NDA · NDA021698

ZANTAC 150

Sponsor: CHATTEM SANOFI

APPLICATION
NDA021698
TYPE
NDA
ORIGINAL APPROVAL
2004-08-31
LATEST ACTION
2019-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZANTAC 150 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
ZANTAC 150 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL

Approval history

2019-09-18Labeling · Supplement 31 · standard — Letter ↗AP
2019-04-04Labeling · Supplement 29 · standard — Label ↗AP
2016-08-26Labeling · Supplement 24 · standard — Letter ↗AP
2016-07-27Labeling · Supplement 23 · standard — Label ↗AP
2016-03-21Labeling · Supplement 22 · standard — Label ↗AP
2015-12-11Labeling · Supplement 19 · standard — Letter ↗AP
2015-11-20Labeling · Supplement 20 · standard — Label ↗AP
2015-03-12Labeling · Supplement 18 · standard — Letter ↗AP
2012-12-07Manufacturing (CMC) · Supplement 13 · standardAP
2007-03-13Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2004-08-31Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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