APPLICATION
ANDA200690
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-01
LATEST ACTION
2026-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-26Labeling · Supplement 4 · standardAP
2026-06-26Labeling · Supplement 5 · standardAP
2016-03-07Manufacturing (CMC) · Supplement 2 · unknownAP
2012-08-01Not Applicable · OriginalAP
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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