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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Covington
Moodys
McKinsey
Fish and Richardson
UBS
Cipla
Medtronic
Daiichi Sankyo
Harvard Business School

Generated: July 27, 2017

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 Alvogen Malta, Par Pharm, and Sigmapharm Labs Llc, 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 three hundred and ninety-two 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: 203918

Tradename:
1
Applicant:
1
Ingredient:
1
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 49884-006-04 1 BOTTLE in 1 CARTON (49884-006-04) > 250 g in 1 BOTTLE

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Moodys
Accenture
Novartis
Fuji
Dow
QuintilesIMS
US Army
Harvard Business School
Boehringer Ingelheim
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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