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Generated: April 26, 2018

DrugPatentWatch Database Preview

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 twenty-six 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 020573
Tradename:BUPHENYL
Applicant:Horizon Pharma Inc
Ingredient:sodium phenylbutyrate
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Pharmacology for NDA: 020573
Mechanism of ActionAmmonium 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 N 75987-070-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength3GM/TEASPOONFUL
Approval Date:Apr 30, 1996TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Merck
Boehringer Ingelheim
McKinsey
Dow
Citi
Queensland Health
AstraZeneca

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