APPLICATION
ANDA075718
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2021-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FAMOTIDINEPrescription
FAMOTIDINE 40MG · TABLET · ORAL
FAMOTIDINEPrescription
FAMOTIDINE 20MG · TABLET · ORAL
Approval history
2021-07-20Labeling · Supplement 17 · standardAP
2012-11-20Labeling · Supplement 15AP
2010-10-29Labeling · Supplement 14AP
2010-07-15Labeling · Supplement 13AP
2007-06-29Labeling · Supplement 10AP
2002-04-19Manufacturing (CMC) · Supplement 3AP
2001-12-13Manufacturing (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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