FDA ANDA · ANDA218866
UPADACITINIB
Sponsor: AUROBINDO PHARMA LTD
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APPLICATION
ANDA218866
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-16
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
UPADACITINIBNone (Tentative Approval)
UPADACITINIB 30MG · TABLET · ORAL
UPADACITINIBNone (Tentative Approval)
UPADACITINIB 15MG · TABLET · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →