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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204395

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NDA 204395 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 twenty-six 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 204395

Tradename:	SODIUM PHENYLBUTYRATE
Applicant:	Par Pharm
Ingredient:	sodium phenylbutyrate
Patents:	0
Therapeutic Class:	Enzyme Replacements/Modifiers
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204395

Mechanism of Action	Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 204395

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	204395	ANDA	Par Pharmaceutical, Inc.	49884-170	N	49884-170-04

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 15, 2016	TE:	AB	RLD:	No

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