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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203631
Company: AMNEAL

Products on ANDA 203631

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM OXYBATE	SODIUM OXYBATE	0.5GM/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203631

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2025	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203631

SODIUM OXYBATE

SOLUTION;ORAL; 0.5GM/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM OXYBATE	SODIUM OXYBATE	0.5GM/ML	SOLUTION;ORAL	Prescription	No	AA	203631	AMNEAL
SODIUM OXYBATE	SODIUM OXYBATE	0.5GM/ML	SOLUTION;ORAL	Prescription	No	AA	210523	ASCENT PHARMS INC
XYREM	SODIUM OXYBATE	0.5GM/ML	SOLUTION;ORAL	Prescription	Yes	AA	021196	JAZZ PHARMS

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