APPLICATION
ANDA076985
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-13
LATEST ACTION
2026-07-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-27Labeling · Supplement 4 · standardAP
2026-07-27Labeling · Supplement 2 · standardAP
2005-09-13OriginalAP
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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