Details for New Drug Application (NDA): 020573

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NDA 020573 describes BUPHENYL, which is a drug marketed by Horizon Pharma Inc 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 are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

Summary for 020573

Tradename:	BUPHENYL
Applicant:	Horizon Pharma Inc
Ingredient:	sodium phenylbutyrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020573

Mechanism of Action	Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 020573

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573	NDA	Horizon Pharma, Inc.	75987-070	75987-070-09	1 BOTTLE in 1 CARTON (75987-070-09) > 250 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	3GM/TEASPOONFUL
Approval Date:	Apr 30, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020573

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Pharma Inc	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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