APPLICATION
ANDA090564
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-22
LATEST ACTION
2026-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
Approval history
2026-07-02Labeling · Supplement 17 · standardAP
2025-11-10Manufacturing (CMC) · Supplement 32 · unknownAP
2019-02-22Labeling · Supplement 15 · standardAP
2017-08-14Manufacturing (CMC) · Supplement 12 · unknownAP
2017-08-14Labeling · Supplement 13 · standardAP
2016-04-05Manufacturing (CMC) · Supplement 5 · unknownAP
2012-01-26Manufacturing (CMC) · Supplement 1AP
2010-04-22OriginalAP
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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