Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220568
Company: NAVINTA LLC

Products on ANDA 220568

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220568

GLYCEROL PHENYLBUTYRATE

LIQUID;ORAL; 1.1GM/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	220313	AUROBINDO PHARMA
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	219540	MSN
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	220568	NAVINTA LLC
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	205742	PH HEALTH
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	No	AA	218738	TEVA PHARMS INC
RAVICTI	GLYCEROL PHENYLBUTYRATE	1.1GM/ML	LIQUID;ORAL	Prescription	Yes	AA	203284	HORIZON THERAP US