← FDA DRUG APPROVALS

FDA NDA · NDA020325

PEPCID AC MAXIMUM STRENGTH

famotidine

Sponsor: KENVUE BRANDS

APPLICATION
NDA020325
TYPE
NDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2026-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

PEPCID AC · ReferenceOver-the-counter
FAMOTIDINE 10MG · TABLET · ORAL
PEPCID AC · ReferenceOver-the-counter
FAMOTIDINE 20MG · TABLET · ORAL

Approval history

2026-02-12Labeling · Supplement 45 · standard — Label ↗AP
2023-12-14Manufacturing (CMC) · Supplement 43 — Label ↗AP
2022-12-15Labeling · Supplement 41 · standard — Letter ↗AP
2022-02-18Manufacturing (CMC) · Supplement 37 — Label ↗AP
2019-04-09Labeling · Supplement 33 · standard — Letter ↗AP
2016-08-01Manufacturing (CMC) · Supplement 31 · standardAP
2016-06-08Labeling · Supplement 30 · standard — Label ↗AP
2016-05-05Manufacturing (CMC) · Supplement 29 · standardAP
2015-07-09Manufacturing (CMC) · Supplement 28 · standardAP
2015-05-06Manufacturing (CMC) · Supplement 27 · standardAP
2015-04-20Manufacturing (CMC) · Supplement 26 · standardAP
2013-04-01Manufacturing (CMC) · Supplement 25 · standardAP
2012-10-11Labeling · Supplement 24 · standard — Label ↗AP
2006-06-09Labeling · Supplement 19 · standard — Letter ↗AP
2004-10-27Labeling · Supplement 17 · standard — Letter ↗AP
2003-09-23Efficacy · Supplement 15 · standard — Review ↗AP
2002-03-01Labeling · Supplement 13 · standard — Letter ↗AP
2000-04-05Manufacturing (CMC) · Supplement 11 · standardAP
2000-02-10Manufacturing (CMC) · Supplement 10 · standardAP
1998-11-09Efficacy · Supplement 7 · standardAP
1998-11-05Manufacturing (CMC) · Supplement 9 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 8 · standardAP
1997-09-26Manufacturing (CMC) · Supplement 6 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 1 · standardAP
1996-05-03Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
1996-04-23Manufacturing (CMC) · Supplement 4 · standardAP
1995-10-02Manufacturing (CMC) · Supplement 2 · standardAP
1995-04-28Type 5 - New Formulation or New Manufacturer · 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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