APPLICATION
ANDA218462
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-03
LATEST ACTION
2025-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-07-18Labeling · Supplement 2 · standardAP
2025-02-14Labeling · Supplement 1 · standardAP
2024-06-03UNKNOWN · Original · 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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