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FDA NDA · NDA206088

OTEZLA

Sponsor: CELGENE CORP

APPLICATION
NDA206088
TYPE
NDA
ORIGINAL APPROVAL
2014-09-23
LATEST ACTION
2014-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OTEZLAPrescription
APREMILAST 30MG · TABLET · ORAL
OTEZLAPrescription
APREMILAST 10MG · TABLET · ORAL
OTEZLAPrescription
APREMILAST 20MG · TABLET · ORAL

Approval history

2014-09-23Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Review ↗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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