OTEZLA
Summary
FDA approved OTEZLA by AMGEN INC. NDA (New Drug) approval (Type 5 - New Formulation or New Manufacturer) on 2025-08-29. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA210745-2
Action Date
2025-08-29
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OTEZLA, TABLET, ORAL. Application: NDA210745
Company
Context & Analysis
AMGEN INC has 9 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
How often does AMGEN INC have FDA actions?
AMGEN INC has 9 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA210745-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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