Application 761128
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS CORP
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761128 | Adakveo | crizanlizumab-tmca | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADAKVEO | CRIZANLIZUMAB-TMCA | 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 |
|---|---|---|---|---|---|---|
| ADAKVEO | CRIZANLIZUMAB | Novartis Pharmaceuticals Corporation | b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6 | 2026-06-04 | Warnings, Adverse reactions | BLA761128 0078-0883 |
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 |
|---|---|---|---|---|---|
| 0078-0883 | ADAKVEO | crizanlizumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0883 | ADAKVEO | crizanlizumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0883 | ADAKVEO | crizanlizumab | Novartis Pharmaceuticals Corporation | BLA | Current |
| 0078-0883 | ADAKVEO | crizanlizumab | Novartis Pharmaceuticals Corporation | BLA | Current |