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FDA ANDA · ANDA215356

TOFACITINIB

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA215356
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-03
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 5MG BASE · TABLET · ORAL
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 10MG BASE · TABLET · ORAL

Approval history

2026-06-03UNKNOWN · Original · standardLetterAP
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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