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FDA ANDA · ANDA078728

GLIPIZIDE AND METFORMIN HCL

Sponsor: HERITAGE

APPLICATION
ANDA078728
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-23
LATEST ACTION
2017-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2017-04-05Labeling · Supplement 5 · standardAP
2017-04-04Labeling · Supplement 2 · standardAP
2010-06-23OriginalAP
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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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