Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219540

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NDA 219540 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 219540

Tradename:	GLYCEROL PHENYLBUTYRATE
Applicant:	Msn
Ingredient:	glycerol phenylbutyrate
Patents:	0

Pharmacology for NDA: 219540

Mechanism of Action	Ammonium Ion Binding Activity

Medical Subject Heading (MeSH) Categories for 219540

Cryoprotective Agents
Solvents

Suppliers and Packaging for NDA: 219540

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	219540	ANDA	Novadoz Pharmaceuticals LLC	72205-331	72205-331-57	1 BOTTLE in 1 CARTON (72205-331-57) / 25 mL in 1 BOTTLE
GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	219540	ANDA	Novadoz Pharmaceuticals LLC	72205-331	72205-331-58	4 BOTTLE in 1 CARTON (72205-331-58) / 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 15, 2026	TE:	AA	RLD:	No

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