APPLICATION
ANDA077270
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-28
LATEST ACTION
2017-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLIPIZIDE AND METFORMIN HYDROCHLORIDEPrescription
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDEPrescription
GLIPIZIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDEPrescription
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
Approval history
2017-04-05Labeling · Supplement 11 · standardAP
2015-08-17Labeling · Supplement 9 · standardAP
2012-04-17Labeling · Supplement 7AP
2010-01-19Labeling · Supplement 4AP
2010-01-19Labeling · Supplement 5AP
2009-01-15Labeling · Supplement 3AP
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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