APPLICATION
ANDA079148
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-25
LATEST ACTION
2026-06-18
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
2026-06-18Labeling · Supplement 7 · standardAP
2026-06-18Labeling · Supplement 6 · standardAP
2012-01-17Manufacturing (CMC) · Supplement 3AP
2008-11-25OriginalAP
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.
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