APPLICATION
ANDA075650
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-14
LATEST ACTION
2002-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FAMOTIDINEDiscontinued
FAMOTIDINE 40MG · TABLET · ORAL
FAMOTIDINEDiscontinued
FAMOTIDINE 20MG · TABLET · ORAL
Approval history
2002-04-23Manufacturing (CMC) · Supplement 1AP
2002-01-07Manufacturing (CMC) · Supplement 2AP
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.