APPLICATION
ANDA075511
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2019-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FAMOTIDINEPrescription
FAMOTIDINE 40MG · TABLET · ORAL
FAMOTIDINEPrescription
FAMOTIDINE 20MG · TABLET · ORAL
Approval history
2019-10-22Labeling · Supplement 23 · standardAP
2014-12-13Labeling · Supplement 18 · standardAP
2012-12-19Labeling · Supplement 15AP
2010-07-06Labeling · Supplement 13AP
2008-02-27Labeling · Supplement 8AP
2003-11-19Labeling · Supplement 5AP
2002-12-20Manufacturing (CMC) · Supplement 2AP
2002-05-08Manufacturing (CMC) · Supplement 1AP
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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