FDA ANDA · ANDA220972
TOFACITINIB CITRATE
Sponsor: SCIEGEN PHARMS
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APPLICATION
ANDA220972
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-25
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval), Prescription
Products
TOFACITINIB CITRATENone (Tentative Approval)
TOFACITINIB CITRATE EQ 22MG BASE · TABLET, EXTENDED RELEASE · ORAL
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-08Labeling · Supplement 1 · standardAP
2026-10-08Labeling · Supplement 2 · standardAP
2026-06-25UNKNOWN · Original · standardAP
2026-06-25UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →