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FDA ANDA · ANDA078321

METFORMIN HYDROCHLORIDE

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APPLICATION
ANDA078321
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-17
LATEST ACTION
2019-01-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-01-02Labeling · Supplement 4 · standardAP
2019-01-02Labeling · Supplement 7 · standardAP
2016-05-12Manufacturing (CMC) · Supplement 3 · unknownAP
2008-04-17OriginalAP
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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