← FDA DRUG APPROVALS

FDA NDA · NDA209806

SEGLUROMET

ertugliflozin and metformin hydrochloride

Sponsor: MSD SUB MERCK

APPLICATION
NDA209806
TYPE
NDA
ORIGINAL APPROVAL
2017-12-19
LATEST ACTION
2024-12-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SEGLUROMET · ReferencePrescription
ERTUGLIFLOZIN 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
SEGLUROMET · ReferencePrescription
ERTUGLIFLOZIN 7.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
SEGLUROMET · ReferencePrescription
ERTUGLIFLOZIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
SEGLUROMET · ReferencePrescription
ERTUGLIFLOZIN 7.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2024-12-20Labeling · Supplement 11 · standard — Letter ↗AP
2023-09-12Labeling · Supplement 10 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 9 · 901 required — Letter ↗AP
2022-03-02Labeling · Supplement 8 · standard — Letter ↗AP
2021-09-17Efficacy · Supplement 6 · standard — Label ↗AP
2020-01-24Labeling · Supplement 2 · 901 required — Label ↗AP
2018-10-26Labeling · Supplement 1 · 901 required — Label ↗AP
2017-12-19Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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