APPLICATION
ANDA077787
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-23
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 4 · standardAP
2025-06-24Labeling · Supplement 5 · standardAP
2008-10-08Labeling · Supplement 3AP
2008-08-15Labeling · Supplement 2AP
2006-08-23OriginalAP
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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