Application 214938
- Type
- NDA
- Sponsor
- BIOMARIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOXZOGO | VOSORITIDE | INJECTABLE;INJECTION | 0.4MG | No | No |
| 002 | VOXZOGO | VOSORITIDE | INJECTABLE;INJECTION | 0.56MG | No | No |
| 003 | VOXZOGO | VOSORITIDE | INJECTABLE;INJECTION | 1.2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68135-082 | VOXZOGO 0.4mg | vosoritide | BioMarin Pharmaceutical Inc. | NDA | Current |
| 68135-119 | VOXZOGO 0.56mg | vosoritide | BioMarin Pharmaceutical Inc. | NDA | Current |
| 68135-181 | VOXZOGO 1.2mg | vosoritide | BioMarin Pharmaceutical Inc. | NDA | Current |