APPLICATION
ANDA203686
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-28
LATEST ACTION
2021-04-30
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
2021-04-30Labeling · Supplement 9 · standardAP
2021-04-30Labeling · Supplement 6 · standardAP
2021-04-30Labeling · Supplement 10 · standardAP
2015-04-13Labeling · Supplement 2 · standardAP
2014-08-28UNKNOWN · 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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