Application 761104
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761104 | Lumoxiti | moxetumomab pasudotox-tdfk | 351(a) | Disc | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUMOXITI | MOXETUMOMAB PASUDOTOX-TDFK | INJECTABLE;INJECTION | 1MG/VIAL | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 14 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-4700 | LUMOXITI | moxetumomab pasudotox | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4700 | LUMOXITI | moxetumomab pasudotox | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4700 | LUMOXITI | moxetumomab pasudotox | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4700 | LUMOXITI | moxetumomab pasudotox | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4700 | LUMOXITI | moxetumomab pasudotox | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4715 | IV Solution Stabilizer | IV Solution Stabilizer | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4715 | IV Solution Stabilizer | IV Solution Stabilizer | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4715 | IV Solution Stabilizer | IV Solution Stabilizer | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4715 | IV Solution Stabilizer | IV Solution Stabilizer | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 0310-4715 | IV Solution Stabilizer | IV Solution Stabilizer | AstraZeneca Pharmaceuticals LP | BLA | Current |
| 73380-4700 | LUMOXITI | MOXETUMOMAB PASUDOTOX | Innate Pharma, Inc. | BLA | Current |
| 73380-4700 | LUMOXITI | MOXETUMOMAB PASUDOTOX | Innate Pharma, Inc. | BLA | Current |
| 73380-4715 | IV STABILIZER | POLYSORBATE 80 | Innate Pharma, Inc. | BLA | Current |
| 73380-4715 | IV STABILIZER | POLYSORBATE 80 | Innate Pharma, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64376 | SUPPL | 2020-08-24 |
| 64347 | SUPPL | 2020-08-21 |
| 64346 | SUPPL | 2020-08-21 |
| 57552 | SUPPL | 2019-02-13 |
| 57369 | SUPPL | 2019-01-29 |
| 57368 | SUPPL | 2019-01-29 |
| 55873 | ORIG | 2018-10-11 |
| 55487 | ORIG | 2018-09-14 |
| 55476 | ORIG | 2018-09-13 |
| 55475 | ORIG | 2018-09-13 |