General MedicationsORALStandard
SODIUM OXYBATE
SODIUM OXYBATE
Standard Dose
0.5GM/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SODIUM OXYBATE is listed in Drugs@FDA under application 210523 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM OXYBATE Form and strength SOLUTION;ORAL - 0.5GM/ML Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-11-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview SODIUM OXYBATE is listed in Drugs@FDA under application 210523 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM OXYBATE Form and strength SOLUTION;ORAL - 0.5GM/ML Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-11-05 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.