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FDA NDA · NDA213082

XELJANZ

tofacitinib

Sponsor: PFIZER

APPLICATION
NDA213082
TYPE
NDA
ORIGINAL APPROVAL
2020-09-25
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XELJANZ · ReferencePrescription
TOFACITINIB CITRATE EQ 1MG BASE/ML · SOLUTION · ORAL

Approval history

2026-06-30Labeling · Supplement 16 · standard — Letter ↗AP
2026-03-06Efficacy · Supplement 13 · standard — Letter ↗AP
2025-10-16Efficacy · Supplement 11 · standard — Letter ↗AP
2025-02-21Efficacy · Supplement 10 · standard — Label ↗AP
2024-09-27Labeling · Supplement 8 · standard — Label ↗AP
2024-05-14Labeling · Supplement 6 · standard — Label ↗AP
2021-12-14Labeling · Supplement 3 · standard — Label ↗AP
2021-12-02Labeling · Supplement 4 · standard — Label ↗AP
2020-09-25Type 3 - New Dosage Form · Original · priority — 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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