General MedicationsORALStandard
METAXALONE
METAXALONE
Standard Dose
640MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview METAXALONE is listed in Drugs@FDA under application 022503 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient METAXALONE Form and strength TABLET;ORAL - 640MG Sponsor PRIMUS PHARMS Submission history Latest submission status date: 2025-05-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview METAXALONE is listed in Drugs@FDA under application 022503 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METAXALONE Form and strength TABLET;ORAL - 640MG Sponsor PRIMUS PHARMS Submission history Latest submission status date: 2025-05-08 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.