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.

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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

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