DANYELZA is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Y-mabs Therapeutics, Inc.. The primary component is Naxitamab.
| Product ID | 73042-201_117c2751-cc38-4d07-9d3c-339b2fe18916 |
| NDC | 73042-201 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DANYELZA |
| Generic Name | Naxitamab |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-11-25 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761171 |
| Labeler Name | Y-mAbs Therapeutics, Inc. |
| Substance Name | NAXITAMAB |
| Active Ingredient Strength | 40 mg/10mL |
| Pharm Classes | Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2020-11-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DANYELZA 88320046 not registered Live/Pending |
Y-mAbs Therapeutics, Inc 2019-02-28 |