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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 three hundred and fifty 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 NDA: 020572

Tradename:
BUPHENYL
Applicant:
Horizon Pharma Inc
Ingredient:
sodium phenylbutyrate
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 13, 1996TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020572

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
TABLET;ORAL020572-001May 13, 19964,457,942► subscribe
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