Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220313
Company: AUROBINDO PHARMA

Products on ANDA 220313

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
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	1.1G/1ML	LIQUID	None (Tentative Approval)	None	No	No
GLYCEROL PHENYLBUTYRATE	GLYCEROL PHENYLBUTYRATE	450ML	LIQUID	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220313

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220313Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 220313

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	207694	LUPIN
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