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FDA NDA · NDA213871

CIBINQO

abrocitinib

Sponsor: PFIZER

APPLICATION
NDA213871
TYPE
NDA
ORIGINAL APPROVAL
2022-01-14
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CIBINQO · ReferencePrescription
ABROCITINIB 200MG · TABLET · ORAL
CIBINQO · ReferencePrescription
ABROCITINIB 50MG · TABLET · ORAL
CIBINQO · ReferencePrescription
ABROCITINIB 100MG · TABLET · ORAL

Approval history

2026-06-30Labeling · Supplement 5 · standard — Letter ↗AP
2023-12-14Efficacy · Supplement 4 · standard — Label ↗AP
2023-02-09Efficacy · Supplement 1 · priority — Label ↗AP
2022-01-14Type 1 - New Molecular Entity · Original · priority — Letter ↗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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