Application 761163
- Type
- BLA
- Sponsor
- MORPHOSYS US INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761163 | Monjuvi | tafasitamab-cxix | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | Monjuvi (tafasitamab-cxix) for injection | TAFASITAMAB-CXIX | INJECTABLE;INJECTION | 12MG/KG | 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 |
|---|---|---|---|---|---|---|
| MONJUVI | TAFASITAMAB-CXIX | Incyte Corporation | ec13ac6b-bfde-4e84-907a-83bd69584d95 | 2026-02-02 | Warnings, Adverse reactions | BLA761163 73535-208 |
| MONJUVI | TAFASITAMAB-CXIX | Incyte Corporation | 9e0a220b-517f-4c86-b581-ffbab493fb58 | 2025-06-23 | Warnings, Adverse reactions | BLA761163 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 73535-208 | MONJUVI | Tafasitamab-cxix | MorphoSys US Inc. | BLA | Current |
| 73535-208 | MONJUVI | Tafasitamab-cxix | MorphoSys US Inc. | BLA | Current |
| 73535-208 | MONJUVI | Tafasitamab-cxix | MorphoSys US Inc. | BLA | Current |
| 73535-208 | MONJUVI | Tafasitamab-cxix | MorphoSys US Inc. | BLA | Current |