APPLICATION
ANDA075978
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2019-02-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
Approval history
2019-02-22Labeling · Supplement 33 · standardAP
2019-02-22Labeling · Supplement 34 · standardAP
2012-06-30Labeling · Supplement 19AP
2009-03-19Labeling · Supplement 27AP
2009-03-12Labeling · Supplement 26AP
2007-04-18Labeling · Supplement 9AP
2007-01-03Labeling · Supplement 8AP
2004-08-06Labeling · Supplement 7AP
2003-01-02Labeling · Supplement 5AP
2002-11-05Manufacturing (CMC) · Supplement 1AP
2002-11-05Labeling · Supplement 4AP
2002-09-04Labeling · Supplement 2AP
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.