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FDA ANDA · ANDA077870
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA077870
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-14
LATEST ACTION
2015-02-18
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
2015-02-18Labeling · Supplement 6AP
2015-02-18Labeling · Supplement 13 · standardAP
2010-05-05Labeling · Supplement 5AP
2009-03-23Labeling · Supplement 3AP
2008-11-21Labeling · Supplement 2AP
2007-11-14OriginalAP
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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