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FDA ANDA · ANDA204720

GLIPIZIDE

Sponsor: UNIQUE

APPLICATION
ANDA204720
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-29
LATEST ACTION
2022-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 2.5MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-07-01Manufacturing (CMC) · Supplement 11 · standardAP
2019-04-23Labeling · Supplement 4 · standardAP
2016-12-29UNKNOWN · OriginalAP
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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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