Elitek Purple Book BLA 103946
- BLA number
- 103946
- Proprietary names
- Elitek
- Proper names
- rasburicase
- Applicant
- Sanofi-Aventis U.S. LLC
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Elitek | rasburicase | 351(a) | 1.5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2002-07-12 | |
| 002 | Elitek | rasburicase | 351(a) | 7.5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2006-01-06 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2021-05-01 | U | 001 | Elitek | 351(a) | Rx | Sanofi-Aventis U.S. LLC |
| 2021-05-01 | U | 002 | Elitek | 351(a) | Rx | Sanofi-Aventis U.S. LLC |
| 2020-08-01 | U | 001 | Elitek | 351(a) | Rx | sanofi-aventis U.S. LLC |
| 2020-08-01 | U | 002 | Elitek | 351(a) | Rx | sanofi-aventis U.S. LLC |
| 2020-05-01 | R | 001 | Elitek | 351(a) | Rx | sanofi-aventis U.S. LLC |
| 2020-05-01 | R | 002 | Elitek | 351(a) | Rx | sanofi-aventis U.S. LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Elitek | 351(a) | Rx | Licensed | 2002-07-12 |
| 2020-05-01 | 002 | Elitek | 351(a) | Rx | Licensed | 2006-01-06 |