PEXEVA
Summary
FDA approved PEXEVA by SEBELA IRELAND LTD. NDA (New Drug) approval (Labeling) on 2023-08-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA021299-35
Action Date
2023-08-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
PEXEVA, TABLET, ORAL. Application: NDA021299
Company
Context & Analysis
Frequently Asked Questions
How often does SEBELA IRELAND LTD have FDA actions?
This is the only FDA action we have on record for SEBELA IRELAND LTD in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA021299-35" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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