Last Updated: September 28, 2026

Details for New Drug Application (NDA): 220579

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NDA 220579 describes GLYCEROL PHENYLBUTYRATE, which is a drug marketed by Aurobindo Pharma, Esjay Pharma, Lupin, MSN, Navinta Llc, Ph Health, and Teva Pharms Inc, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the GLYCEROL PHENYLBUTYRATE profile page.

The generic ingredient in GLYCEROL PHENYLBUTYRATE is glycerol phenylbutyrate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

Summary for 220579

Tradename:	GLYCEROL PHENYLBUTYRATE
Applicant:	Esjay Pharma
Ingredient:	glycerol phenylbutyrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 220579

Cryoprotective Agents
Solvents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;ORAL			Strength	1.1GM/ML
Approval Date:	Jul 28, 2026	TE:	AA	RLD:	No

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