APPLICATION
ANDA209738
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-13
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 5MG BASE · TABLET · ORAL
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 10MG BASE · TABLET · ORAL
Approval history
2026-06-03UNKNOWN · Original · standardAP
2025-07-21Labeling · Supplement 1 · standardAP
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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