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FDA ANDA · ANDA090888

METFORMIN HCL

Sponsor: MARKSANS PHARMA

APPLICATION
ANDA090888
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-12
LATEST ACTION
2019-02-22
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

2019-02-22Labeling · Supplement 4 · standardAP
2014-12-22Manufacturing (CMC) · Supplement 1 · unknownAP
2012-03-12OriginalAP
VIEW ON DRUGS@FDA ↗

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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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