APPLICATION
ANDA075704
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-16
LATEST ACTION
2020-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FAMOTIDINEPrescription
FAMOTIDINE 20MG · TABLET · ORAL
FAMOTIDINEPrescription
FAMOTIDINE 40MG · TABLET · ORAL
Approval history
2020-05-13Labeling · Supplement 19 · standardAP
2020-05-13Labeling · Supplement 18 · standardAP
2016-05-16Labeling · Supplement 16 · standardAP
2013-06-27Labeling · Supplement 15 · standardAP
2003-05-14Labeling · Supplement 3AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.