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FDA NDA · NDA020801

PEPCID AC

Sponsor: KENVUE BRANDS

APPLICATION
NDA020801
TYPE
NDA
ORIGINAL APPROVAL
1998-09-24
LATEST ACTION
2019-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter, Discontinued

Products

PEPCID AC · ReferenceOver-the-counter
FAMOTIDINE 20MG · TABLET, CHEWABLE · ORAL
PEPCID AC · ReferenceDiscontinued
FAMOTIDINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2019-10-29Labeling · Supplement 20 · standard — Label ↗AP
2014-03-20Manufacturing (CMC) · Supplement 18 · standardAP
2013-09-11Manufacturing (CMC) · Supplement 17 · standardAP
2013-04-01Manufacturing (CMC) · Supplement 16 · standardAP
2007-12-17Efficacy · Supplement 12 · unknown — Review ↗AP
2004-10-27Labeling · Supplement 10 · standard — Letter ↗AP
2002-01-31Labeling · Supplement 7 · standard — Letter ↗AP
2001-03-29Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2000-04-26Manufacturing (CMC) · Supplement 3 · standardAP
2000-04-06Labeling · Supplement 2 · standardAP
1999-08-20Manufacturing (CMC) · Supplement 1 · standardAP
1998-09-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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