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Generated: November 14, 2018

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Details for New Drug Application (NDA): 020572

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NDA 020572 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 fifty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 020572
Tradename:BUPHENYL
Applicant:Horizon Pharma Inc
Ingredient:sodium phenylbutyrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020572
Mechanism of ActionAmmonium 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 Pharma, 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:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 13, 1996TE:ABRLD:Yes

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