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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220418
Company: NAVINTA LLC

Products on ANDA 220418

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220418

SODIUM PHENYLBUTYRATE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	No	AB	216462	GLENMARK PHARMS LTD
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	No	AB	220418	NAVINTA LLC
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	500MG	TABLET;ORAL	Prescription	No	AB	204395	PH HEALTH

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