Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020572

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NDA 020572 describes BUPHENYL, which is a drug marketed by Horizon Therap Us and is included in two NDAs. It is available from one supplier. Additional details are available on the BUPHENYL profile page.

The generic ingredient in BUPHENYL is sodium phenylbutyrate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

Summary for 020572

Tradename:	BUPHENYL
Applicant:	Horizon Therap Us
Ingredient:	sodium phenylbutyrate
Patents:	0

Pharmacology for NDA: 020572

Mechanism of Action	Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 020572

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572	NDA	Horizon Therapeutics USA, Inc.	75987-060	75987-060-08	1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 13, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020572

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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