Ziextenzo Purple Book BLA 761045
- BLA number
- 761045
- Proprietary names
- Ziextenzo
- Proper names
- pegfilgrastim-bmez
- Applicant
- Sandoz Inc.
- Center
- CDER
- First observed release
- 2020-02-01
- 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 | Ziextenzo | pegfilgrastim-bmez | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2019-11-04 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125031 | Neulasta | pegfilgrastim | 351(a) | Rx | 2026-06-01 |
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.
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Ziextenzo | 351(k) Biosimilar | Rx | Licensed | 2019-11-04 |
| 2020-02-01 | 001 | Ziextenzo | 351(k) Biosimilar | Marketed | Licensed | 2019-11-04 |