Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220568

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NDA 220568 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 220568

Tradename:	GLYCEROL PHENYLBUTYRATE
Applicant:	Navinta Llc
Ingredient:	glycerol phenylbutyrate
Patents:	0

Pharmacology for NDA: 220568

Mechanism of Action	Ammonium Ion Binding Activity

Medical Subject Heading (MeSH) Categories for 220568

Cryoprotective Agents
Solvents

Suppliers and Packaging for NDA: 220568

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	220568	ANDA	Navinta LLC	68475-807	68475-807-01	1 BOTTLE in 1 CARTON (68475-807-01) / 25 mL in 1 BOTTLE
GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	220568	ANDA	Zydus Pharmaceuticals USA Inc.	70710-2193	70710-2193-5	1 BOTTLE in 1 CARTON (70710-2193-5) / 25 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;ORAL			Strength	1.1GM/ML
Approval Date:	Apr 23, 2026	TE:	AA	RLD:	No

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