APPLICATION
ANDA075979
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-24
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 18 · standardAP
2026-07-14Labeling · Supplement 17 · standardAP
2005-03-04Labeling · Supplement 10AP
2004-04-01Labeling · Supplement 9AP
2003-02-27Labeling · Supplement 3AP
2002-10-11Manufacturing (CMC) · Supplement 5AP
2002-08-13Labeling · Supplement 6AP
2002-04-22Labeling · Supplement 4AP
2002-01-24OriginalAP
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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