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FDA ANDA · ANDA075965

METFORMIN HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA075965
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2019-08-28
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

2019-08-28Labeling · Supplement 18 · standardAP
2019-08-28Labeling · Supplement 17 · standardAP
2010-05-20Labeling · Supplement 12AP
2002-10-02Manufacturing (CMC) · Supplement 3AP
2002-08-22Labeling · Supplement 2AP
2002-07-01Manufacturing (CMC) · Supplement 1AP
2002-01-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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