Application 761142
- Type
- BLA
- Sponsor
- VIELA BIO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UPLIZNA | INEBILIZUMAB | INJECTABLE;INJECTION | 100MG/10ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72677-551 | UPLIZNA | Inebilizumab | Viela Bio, Inc. | BLA | Current |
| 72677-551 | UPLIZNA | Inebilizumab | Viela Bio, Inc. | BLA | Current |
| 72677-551 | UPLIZNA | Inebilizumab | Viela Bio, Inc. | BLA | Current |
| 72677-551 | UPLIZNA | Inebilizumab | Viela Bio, Inc. | BLA | Current |
| 72677-551 | UPLIZNA | Inebilizumab | Viela Bio, Inc. | BLA | Current |
| 75987-150 | UPLIZNA | Inebilizumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-150 | UPLIZNA | Inebilizumab | Horizon Therapeutics USA, Inc. | BLA | Current |
| 75987-150 | UPLIZNA | Inebilizumab | Horizon Therapeutics USA, Inc. | BLA | Current |