FDA ANDA · ANDA220458
TOFACITINIB CITRATE
Sponsor: APOTEX
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APPLICATION
ANDA220458
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-03
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-14Labeling · Supplement 1 · standardAP
2026-06-03UNKNOWN · Original · standardAP
2026-06-03UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →