APPLICATION
ANDA076878
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-13
LATEST ACTION
2026-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-14Labeling · Supplement 16 · standardAP
2026-07-14Labeling · Supplement 15 · standardAP
2008-12-22Labeling · Supplement 12AP
2005-04-13OriginalAP
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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