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FDA ANDA · ANDA218668

TOFACITINIB

Sponsor: DEXCEL

APPLICATION
ANDA218668
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-16
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval), Prescription

Products

TOFACITINIB CITRATENone (Tentative Approval)
TOFACITINIB CITRATE 22MG · TABLET, EXTENDED RELEASE · ORAL
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-12-16UNKNOWN · Original · standardLetterAP
2024-12-16UNKNOWN · Original · standardLetterTA
VIEW ON DRUGS@FDA ↗

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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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