FDA
Sodium Oxybate
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- SODIUM OXYBATE 500MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA203351.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Sodium Oxybate
- Route
- Oral
- Dosage form
- Solution
- Applicant
- Ohm Labs Inc
- Status
- Tentative approval
- FDA approval
- 19 Jan 2017
- Application
- ANDA203351-001