← FDA DRUG APPROVALS

FDA NDA · NDA022503

METAXALONE

Sponsor: PRIMUS PHARMS

APPLICATION
NDA022503
TYPE
NDA
ORIGINAL APPROVAL
2015-06-01
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METAXALONE · ReferencePrescription
METAXALONE 640MG · TABLET · ORAL

Approval history

2025-05-08Labeling · Supplement 4 · standard — Letter ↗AP
2024-01-10Labeling · Supplement 3 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 1 · standard — Letter ↗AP
2015-06-01Type 3 - New Dosage Form · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →