Application 761128
- Type
- BLA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADAKVEO | CRIZANLIZUMAB-TMCA | INJECTABLE; INJECTION | 100MG/10ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78972 | SUPPL | 2024-07-02 |
| 78909 | SUPPL | 2024-06-28 |
| 72058 | SUPPL | 2022-09-10 |
| 72054 | SUPPL | 2022-09-09 |
| 68086 | SUPPL | 2021-07-14 |
| 68079 | SUPPL | 2021-07-14 |
| 61294 | ORIG | 2019-12-17 |
| 60957 | ORIG | 2019-11-19 |
| 60858 | ORIG | 2019-11-15 |