APPLICATION
ANDA077060
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-20
LATEST ACTION
2026-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-15Labeling · Supplement 5 · standardAP
2026-07-15Labeling · Supplement 6 · standardAP
2008-10-31Labeling · Supplement 3AP
2008-01-28Labeling · Supplement 2AP
2005-04-20OriginalAP
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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