← FDA DRUG APPROVALS

FDA NDA · NDA020958

PEPCID COMPLETE

famotidine, calcium carbonate, magnesium hydroxide chewable tablet

Sponsor: KENVUE BRANDS

APPLICATION
NDA020958
TYPE
NDA
ORIGINAL APPROVAL
2000-10-16
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter

Products

PEPCID COMPLETE · ReferenceOver-the-counter
CALCIUM CARBONATE 800MG, FAMOTIDINE 10MG, MAGNESIUM HYDROXIDE 165MG · TABLET, CHEWABLE · ORAL

Approval history

2025-09-30Labeling · Supplement 44 · standard — Letter ↗AP
2025-02-11Labeling · Supplement 43 · standard — Letter ↗AP
2025-01-31Labeling · Supplement 41 · standard — Label ↗AP
2025-01-17Manufacturing (CMC) · Supplement 42 — Label ↗AP
2019-06-11Labeling · Supplement 29 · standard — Letter ↗AP
2019-04-09Labeling · Supplement 28 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 27 · standard — Label ↗AP
2016-06-08Labeling · Supplement 25 · standard — Letter ↗AP
2015-07-14Manufacturing (CMC) · Supplement 23 · standardAP
2014-03-20Manufacturing (CMC) · Supplement 21 · standardAP
2013-12-07Manufacturing (CMC) · Supplement 20 · standardAP
2013-07-30Labeling · Supplement 18 · standard — Letter ↗AP
2013-04-01Manufacturing (CMC) · Supplement 17 · standardAP
2008-11-18Manufacturing (CMC) · Supplement 15 — Review ↗AP
2006-06-09Labeling · Supplement 13 · standard — Letter ↗AP
2005-07-18Labeling · Supplement 12 · standard — Letter ↗AP
2004-10-27Labeling · Supplement 10 · standard — Letter ↗AP
2003-11-05Labeling · Supplement 7 · standard — Letter ↗AP
2002-11-22Manufacturing (CMC) · Supplement 3 · standardAP
2001-11-06Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
2001-09-24Manufacturing (CMC) · Supplement 1 · standardAP
2000-10-16Type 4 - New Combination · Original · standard — Letter ↗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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