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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 two suppliers. Additional details are available on the BUPHENYL profile page.

The generic ingredient in BUPHENYL is sodium phenylbutyrate. There are one thousand three hundred and thirty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

Summary for NDA: 020573

Horizon Pharma Inc
sodium phenylbutyrate
Therapeutic Class:Enzyme Replacements/Modifiers

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
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
sodium phenylbutyrate
POWDER;ORAL 020573 NDA Hyperion Therapeutics, Inc. 76325-188 76325-188-64 1 BOTTLE in 1 CARTON (76325-188-64) > 250 g in 1 BOTTLE

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020573

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Inc
sodium phenylbutyrate
POWDER;ORAL020573-001Apr 30, 19964,457,942<subscribe>
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