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FDA ANDA · ANDA205096

METFORMIN HYDROCHLORIDE

Sponsor: CSPC OUYI

APPLICATION
ANDA205096
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-11
LATEST ACTION
2021-06-28
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

2021-06-28Labeling · Supplement 6 · standardAP
2021-06-28Labeling · Supplement 2 · standardAP
2016-07-11UNKNOWN · Original · standard — Letter ↗AP
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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