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FDA ANDA · ANDA219830

TOFACITINIB

Sponsor: ORIENT PHARMA

APPLICATION
ANDA219830
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-09
LATEST ACTION
2026-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-09UNKNOWN · Original · standardAP
2026-06-09UNKNOWN · Original · standardTA
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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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