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.
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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216513
| Mechanism of Action | Ammonium 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: | RX | Dosage: | PELLETS;ORAL | Strength | 84GM/BOT | ||||
| Approval Date: | Jun 17, 2022 | TE: | RLD: | Yes | |||||
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