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FDA ANDA · ANDA076716

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA076716
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-28
LATEST ACTION
2021-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 1.25MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEPrescription
GLYBURIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2021-03-04Labeling · Supplement 36 · standardAP
2021-03-04Labeling · Supplement 28 · standardAP
2021-03-04Labeling · Supplement 32 · standardAP
2011-09-27Labeling · Supplement 20AP
2010-08-11Labeling · Supplement 17AP
2010-01-19Labeling · Supplement 15AP
2010-01-19Labeling · Supplement 14AP
2005-06-28OriginalAP
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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