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FDA NDA · NDA211192

TIBSOVO

ivosidenib

Sponsor: SERVIER

APPLICATION
NDA211192
TYPE
NDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2023-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TIBSOVO · ReferencePrescription
IVOSIDENIB 250MG · TABLET · ORAL

Approval history

2023-10-24Efficacy · Supplement 11 · priority — Label ↗AP
2022-05-25Efficacy · Supplement 9 · priority — Label ↗AP
2021-08-25Efficacy · Supplement 8 · priority — Label ↗AP
2021-03-18Labeling · Supplement 7 · standard — Letter ↗AP
2020-03-17Labeling · Supplement 2 · standard — Letter ↗AP
2019-05-02Efficacy · Supplement 1 · priority — Label ↗AP
2018-07-20Type 1 - New Molecular Entity · Original · priority — 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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