Application 216513
- Type
- NDA
- Sponsor
- MEDUNIK CANADA INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHEBURANE | SODIUM PHENYLBUTYRATE | PELLETS;ORAL | 84GM/BOT | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71770-100 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
| 71770-200 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
| 71770-200 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
| 71770-200 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
| 71770-210 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
| 71770-210 | PHEBURANE | Sodium phenylbutyrate | Medunik USA | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73749 | ORIG | 2023-03-14 |
| 71417 | ORIG | 2022-06-21 |
| 71385 | ORIG | 2022-06-21 |