Application 761116
- Type
- BLA
- Sponsor
- STEMLINE THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ELZONRIS | TAGRAXOFUSP-ERZS | SOLUTION;INJECTION | 1000MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74909 | SUPPL | 2023-07-27 |
| 74901 | SUPPL | 2023-07-27 |
| 72570 | SUPPL | 2022-11-07 |
| 72559 | SUPPL | 2022-11-04 |
| 72494 | SUPPL | 2022-10-28 |
| 72491 | SUPPL | 2022-10-28 |
| 57350 | ORIG | 2019-01-28 |
| 56969 | ORIG | 2018-12-21 |