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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216513


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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

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