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FDA NDA · NDA209803

STEGLATRO

ertugliflozin

Sponsor: MSD SUB MERCK

APPLICATION
NDA209803
TYPE
NDA
ORIGINAL APPROVAL
2017-12-19
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

STEGLATRO · ReferencePrescription
ERTUGLIFLOZIN 5MG · TABLET · ORAL
STEGLATRO · ReferencePrescription
ERTUGLIFLOZIN 15MG · TABLET · ORAL

Approval history

2026-06-03Labeling · Supplement 12 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 8 · standard — Letter ↗AP
2023-09-12Labeling · Supplement 7 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 6 · 901 required — Letter ↗AP
2021-09-17Efficacy · Supplement 4 · standard — Label ↗AP
2020-01-24Labeling · Supplement 2 · 901 required — Label ↗AP
2018-10-26Labeling · Supplement 1 · 901 required — Label ↗AP
2017-12-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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