Application 761142
- Type
- BLA
- Sponsor
- VIELA BIO
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761142 | Uplizna | inebilizumab-cdon | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | UPLIZNA | INEBILIZUMAB | INJECTABLE;INJECTION | 100MG/10ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 8 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84445 | SUPPL | 2025-12-18 |
| 84399 | SUPPL | 2025-12-12 |
| 81878 | SUPPL | 2025-04-08 |
| 81825 | SUPPL | 2025-04-03 |
| 81824 | SUPPL | 2025-04-03 |
| 63793 | ORIG | 2020-07-06 |
| 63505 | ORIG | 2020-06-12 |
| 63503 | ORIG | 2020-06-12 |
| 63495 | ORIG | 2020-06-12 |