APPLICATION
ANDA216947
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-13
LATEST ACTION
2025-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ERTUGLIFLOZINDiscontinued
ERTUGLIFLOZIN 5MG · TABLET · ORAL
ERTUGLIFLOZINDiscontinued
ERTUGLIFLOZIN 15MG · TABLET · ORAL
Approval history
2025-12-03Labeling · Supplement 3 · standardAP
2024-12-09Labeling · Supplement 2 · standardAP
2024-07-11Labeling · Supplement 1 · 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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