Last Updated: September 24, 2026

Details for New Drug Application (NDA): 220313

✉ Email this page to a colleague

« Back to Dashboard

NDA 220313 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.