FDA ANDA · ANDA219442
TOFACITINIB CITRATE
Sponsor: BIOCON PHARMA
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APPLICATION
ANDA219442
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-17
LATEST ACTION
2026-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription, None (Tentative Approval)
Products
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL
TOFACITINIB CITRATENone (Tentative Approval)
TOFACITINIB CITRATE EQ 22MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-09Labeling · Supplement 1 · standardAP
2026-10-09Labeling · Supplement 2 · standardAP
2025-11-17UNKNOWN · Original · standardTA
2025-11-17UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →