APPLICATION
ANDA075961
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2026-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2026-07-14Labeling · Supplement 31 · standardAP
2026-07-14Labeling · Supplement 32 · standardAP
2008-10-31Labeling · Supplement 20AP
2007-05-25Labeling · Supplement 15AP
2002-12-24Manufacturing (CMC) · Supplement 5AP
2002-10-08Manufacturing (CMC) · Supplement 4AP
2002-06-21Manufacturing (CMC) · Supplement 2AP
2002-06-21Manufacturing (CMC) · Supplement 1AP
2002-04-08Labeling · Supplement 3AP
2002-01-25OriginalAP
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.