Last Updated: November 9, 2026

Details for New Drug Application (NDA): 202090

NDA 202090 describes SODIUM OXYBATE, which is a drug marketed by Amneal, Ascent Pharms Inc, and Hikma, and is included in three NDAs. It is available from three suppliers. Additional details are available on the SODIUM OXYBATE profile page.

The generic ingredient in SODIUM OXYBATE is sodium oxybate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

Summary for 202090

Tradename:	SODIUM OXYBATE
Applicant:	Hikma
Ingredient:	sodium oxybate
Patents:	0

Medical Subject Heading (MeSH) Categories for 202090

Adjuvants, Anesthesia
Anesthetics, Intravenous

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	0.5GM/ML
Approval Date:	Jan 17, 2017	TE:		RLD:	No

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