APPLICATION
ANDA077124
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-21
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METFORMIN HYDROCHLORIDEDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-29Labeling · Supplement 10 · standardAP
2008-11-13Labeling · Supplement 8AP
2007-03-16Labeling · Supplement 5AP
2005-12-21OriginalAP
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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