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Last Updated: June 4, 2023

Details for New Drug Application (NDA): 020573

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NDA 020573 describes BUPHENYL, which is a drug marketed by Horizon Therap 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. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 020573
Applicant:Horizon Therap
Ingredient:sodium phenylbutyrate
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 Therapeutics USA, 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:RXDosage:POWDER;ORALStrength3GM/TEASPOONFUL
Approval Date:Apr 30, 1996TE:ABRLD:Yes

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