FDA NDA · NDA207924

OLUMIANT

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APPLICATION
NDA207924
TYPE
NDA
ORIGINAL APPROVAL
2018-05-31
LATEST ACTION
2026-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OLUMIANT · ReferencePrescription
BARICITINIB 1MG · TABLET · ORAL
OLUMIANT · ReferencePrescription
BARICITINIB 4MG · TABLET · ORAL
OLUMIANT · ReferencePrescription
BARICITINIB 2MG · TABLET · ORAL

Approval history

2026-10-09Efficacy · Supplement 10 · standard — Letter ↗AP
2026-09-25Efficacy · Supplement 9 · standard — Letter ↗AP
2026-06-30Labeling · Supplement 11 · standard — Letter ↗AP
2022-06-13Efficacy · Supplement 7 · priority — Letter ↗AP
2022-05-10Efficacy · Supplement 6 · priority — Label ↗AP
2021-12-02Labeling · Supplement 4 · standard — Label ↗AP
2020-07-08Labeling · Supplement 2 · standard — Letter ↗AP
2019-10-08Efficacy · Supplement 1 · standard — Letter ↗AP
2018-05-31Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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