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FDA ANDA · ANDA079118

METFORMIN HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA079118
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-20
LATEST ACTION
2024-04-15
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

2024-04-15Manufacturing (CMC) · Supplement 16 · unknownAP
2019-01-02Labeling · Supplement 8 · standardAP
2019-01-02Labeling · Supplement 9 · standardAP
2012-07-20OriginalAP
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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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