You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 7, 2024

Details for New Drug Application (NDA): 216513


✉ Email this page to a colleague

« Back to Dashboard


NDA 216513 describes PHEBURANE, which is a drug marketed by Medunik and is included in one NDA. It is available from one supplier. Additional details are available on the PHEBURANE profile page.

The generic ingredient in PHEBURANE 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 216513
Tradename:PHEBURANE
Applicant:Medunik
Ingredient:sodium phenylbutyrate
Patents:0
Pharmacology for NDA: 216513
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 216513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHEBURANE sodium phenylbutyrate PELLETS;ORAL 216513 NDA Medunik USA 71770-200 71770-200-10 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10)
PHEBURANE sodium phenylbutyrate PELLETS;ORAL 216513 NDA Medunik USA 71770-210 71770-210-10 174 g in 1 BOTTLE (71770-210-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength84GM/BOT
Approval Date:Jun 17, 2022TE:RLD:Yes

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.