APPLICATION
ANDA077064
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-18
LATEST ACTION
2026-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2026-07-23Labeling · Supplement 28 · standardAP
2026-07-23Labeling · Supplement 29 · standardAP
2015-04-13Labeling · Supplement 26 · standardAP
2011-05-19Labeling · Supplement 15AP
2010-04-12Labeling · Supplement 8AP
2009-12-28Labeling · Supplement 16AP
2009-08-11Labeling · Supplement 12AP
2008-01-28Labeling · Supplement 9AP
2005-04-18OriginalAP
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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