Application 761116
- Type
- BLA
- Sponsor
- STEMLINE THERAPEUTICS INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761116 | Elzonris | tagraxofusp-erzs | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELZONRIS | TAGRAXOFUSP-ERZS | SOLUTION;INJECTION | 1000MCG | 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 |
|---|---|---|---|---|---|---|
| Elzonris | TAGRAXOFUSP | Stemline Therapeutics, Inc. | 80eb1080-fe20-4af0-b2a5-a67999923fa8 | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | BLA761116 72187-0401 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72187-0401 | Elzonris | tagraxofusp | Stemline Therapeutics, Inc. | BLA | Current |
| 72187-0401 | Elzonris | tagraxofusp | Stemline Therapeutics, Inc. | BLA | Current |
| 72187-0401 | Elzonris | tagraxofusp | Stemline Therapeutics, Inc. | BLA | Current |
| 72187-0401 | Elzonris | tagraxofusp | Stemline Therapeutics, Inc. | BLA | Current |
| 72187-0401 | Elzonris | tagraxofusp | Stemline Therapeutics, Inc. | BLA | Current |