METAXALONE
Summary
FDA approved METAXALONE by PRIMUS PHARMS. NDA (New Drug) approval (Labeling) on 2025-05-08. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA022503-4
Action Date
2025-05-08
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
METAXALONE, TABLET, ORAL. Application: NDA022503
Company
Context & Analysis
Frequently Asked Questions
How often does PRIMUS PHARMS have FDA actions?
This is the only FDA action we have on record for PRIMUS PHARMS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA022503-4" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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