Application 761171
- Type
- BLA
- Sponsor
- Y-MABS THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DANYELZA | NAXITAMAB-GQGK | SOLUTION;INTRAVENOUS | 40MG/10ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73042-201 | DANYELZA | Naxitamab | Y-mAbs Therapeutics, Inc. | BLA | Current |
| 73042-201 | DANYELZA | Naxitamab | Y-mAbs Therapeutics, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83234 | SUPPL | 2025-08-29 |
| 83216 | SUPPL | 2025-08-28 |
| 77910 | SUPPL | 2024-03-21 |
| 77898 | SUPPL | 2024-03-21 |
| 65696 | ORIG | 2020-12-22 |
| 65359 | ORIG | 2020-11-27 |
| 65350 | ORIG | 2020-11-25 |