Details for New Drug Application (NDA): 216513
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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 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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