Generic Companies with Tentative Approvals for: sodium oxybate
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sodium oxybate Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Ohm Labs Inc | sodium oxybate | 203351 | 500MG/ML | SOLUTION;ORAL |
Avadel Cns Pharma Llc | sodium oxybate | 214755 | 7.5G | SUSPENSION;ORAL |
Avadel Cns Pharma Llc | sodium oxybate | 214755 | 9G | SUSPENSION;ORAL |
Amneal Pharms | sodium oxybate | 203631 | 500MG/ML | SOLUTION;ORAL |
Avadel Cns Pharma Llc | sodium oxybate | 214755 | 4.5G | SUSPENSION;ORAL |
Avadel Cns Pharma Llc | sodium oxybate | 214755 | 6G | SUSPENSION;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |