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Medtronic
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Accenture
Fish and Richardson
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Chinese Patent Office
Chubb
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203918

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NDA 203918 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Par Pharm, Sigmapharm Labs Llc, and Alvogen Malta, and is included in four NDAs. It is available from three suppliers. Additional details are available on the SODIUM PHENYLBUTYRATE profile page.

The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There are one thousand four hundred and fifteen 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 203918
Tradename:SODIUM PHENYLBUTYRATE
Applicant:Par Pharm
Ingredient:sodium phenylbutyrate
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Pharmacology for NDA: 203918
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 203918
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 203918 ANDA Par Pharmaceutical, Inc. 49884-006 N 49884-006-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength3GM/TEASPOONFUL
Approval Date:Jun 15, 2016TE:ABRLD:No

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