← FDA DRUG APPROVALS

FDA NDA · NDA020902

PEPCID AC

Sponsor: J AND J CONSUMER INC

APPLICATION
NDA020902
TYPE
NDA
ORIGINAL APPROVAL
1999-08-05
LATEST ACTION
2006-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PEPCID ACDiscontinued
FAMOTIDINE 10MG · TABLET · ORAL

Approval history

2006-06-09Labeling · Supplement 9 · standard — Letter ↗AP
2004-10-27Labeling · Supplement 7 · standard — Letter ↗AP
2002-01-31Labeling · Supplement 5 · standardAP
2000-07-13Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-05Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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