Application 761142
- Type
- BLA
- Sponsor
- VIELA BIO
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761142 | Uplizna | inebilizumab-cdon | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UPLIZNA | INEBILIZUMAB | INJECTABLE;INJECTION | 100MG/10ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| UPLIZNA | INEBILIZUMAB | Horizon Therapeutics USA, Inc. | 834db232-afb0-4dcf-93e0-009ce8245c20 | 2025-12-11 | Warnings, Adverse reactions | BLA761142 75987-150 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |