← FDA DRUG APPROVALS

FDA NDA · NDA210745

OTEZLA

Sponsor: AMGEN INC

APPLICATION
NDA210745
TYPE
NDA
ORIGINAL APPROVAL
2025-08-29
LATEST ACTION
2025-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET, TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

OTEZLAPrescription
APREMILAST 30MG · TABLET · ORAL
OTEZLAPrescription
APREMILAST 20MG · TABLET · ORAL
OTEZLA XR · ReferencePrescription
APREMILAST 75MG · TABLET, EXTENDED RELEASE · ORAL
OTEZLAPrescription
APREMILAST 10MG · TABLET · ORAL

Approval history

2025-08-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
2025-08-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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