APTIOM (ESLICARBAZEPINE ACETATE)
Summary
FDA approved APTIOM (ESLICARBAZEPINE ACETATE) by SUMITOMO PHARMA AM. NDA (New Drug) approval (Manufacturing (CMC)) on 2024-06-20. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA022416-21
Action Date
2024-06-20
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
APTIOM (generic: ESLICARBAZEPINE ACETATE), TABLET, ORAL. Application: NDA022416
Company
Context & Analysis
SUMITOMO PHARMA AM has 2 FDA actions in our database.
Frequently Asked Questions
How often does SUMITOMO PHARMA AM have FDA actions?
SUMITOMO PHARMA AM has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA022416-21" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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