You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202819


✉ Email this page to a colleague

« Back to Dashboard


NDA 202819 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Par Pharm, Sigmapharm Labs Llc, Alvogen, and Glenmark Pharms Ltd, and is included in five 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 seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 202819
Tradename:SODIUM PHENYLBUTYRATE
Applicant:Sigmapharm Labs Llc
Ingredient:sodium phenylbutyrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202819
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 202819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM PHENYLBUTYRATE sodium phenylbutyrate POWDER;ORAL 202819 ANDA Sigmapharm Laboratories, LLC 42794-086 42794-086-14 1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength3GM/TEASPOONFUL
Approval Date:Mar 22, 2013TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.