General MedicationsORALGeneric
SODIUM OXYBATE
SODIUM OXYBATE
Standard Dose
500MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview SODIUM OXYBATE is listed in Drugs@FDA under application 203351 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SODIUM OXYBATE Form and strength SOLUTION;ORAL - 500MG/ML Sponsor OHM LABS INC Submission history Latest submission status date: 2017-01-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview SODIUM OXYBATE is listed in Drugs@FDA under application 203351 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SODIUM OXYBATE Form and strength SOLUTION;ORAL - 500MG/ML Sponsor OHM LABS INC Submission history Latest submission status date: 2017-01-19 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.