APPLICATION
ANDA206928
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-12
LATEST ACTION
2023-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GLIPIZIDEPrescription
GLIPIZIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 2.5MG · TABLET, EXTENDED RELEASE · ORAL
GLIPIZIDEPrescription
GLIPIZIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-03-13Manufacturing (CMC) · Supplement 10 · unknownAP
2019-10-11Labeling · Supplement 4 · standardAP
2019-10-11Labeling · Supplement 2 · standardAP
2017-05-12UNKNOWN · Original · standardAP
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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