Last Updated: June 9, 2026

Details for New Drug Application (NDA): 220313

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NDA 220313 describes GLYCEROL PHENYLBUTYRATE, which is a drug marketed by Aurobindo Pharma, Lupin, MSN, Navinta Llc, Ph Health, and Teva Pharms Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the GLYCEROL PHENYLBUTYRATE profile page.

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

Summary for 220313

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

Pharmacology for NDA: 220313

Mechanism of Action	Ammonium Ion Binding Activity

Medical Subject Heading (MeSH) Categories for 220313

Cryoprotective Agents
Solvents

Suppliers and Packaging for NDA: 220313

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	220313	ANDA	Aurobindo Pharma Limited	59651-988	59651-988-25	1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;ORAL			Strength	1.1GM/ML
Approval Date:	Apr 15, 2026	TE:	AA	RLD:	No

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