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General MedicationsORALStandard

XYWAV

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Standard Dose
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview XYWAV is listed in Drugs@FDA under application 212690 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE Form and strength SOLUTION;ORAL - 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML Sponsor JAZZ Submission history Latest submission status date: 2025-07-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview XYWAV is listed in Drugs@FDA under application 212690 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE Form and strength SOLUTION;ORAL - 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML Sponsor JAZZ Submission history Latest submission status date: 2025-07-28 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.