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FDA ANDA · ANDA077507
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Sponsor: EPIC PHARMA LLC
APPLICATION
ANDA077507
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-27
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 4 · standardAP
2010-08-26Labeling · Supplement 3AP
2009-10-26Labeling · Supplement 2AP
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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