Garzulys Purple Book BLA 761497
- BLA number
- 761497
- Proprietary names
- Garzulys
- Proper names
- insulin aspart-fsan
- Applicant
- Emerge Bioscience Pte. Ltd.
- Center
- CDER
- First observed release
- 2026-07-01
- Latest observed release
- 2026-07-01
- Newest archive release
- 2026-07-01
- 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 | Garzulys | insulin aspart-fsan | 351(k) Biosimilar | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2026-07-24 | |
| 002 | Garzulys | insulin aspart-fsan | 351(k) Biosimilar | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2026-07-24 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 020986 | Novolog | insulin aspart | 351(a) | Rx | 2026-07-01 |
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.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-07-01 | N | 001 | Garzulys | 351(k) Biosimilar | Rx | Emerge Bioscience Pte. Ltd. |
| 2026-07-01 | N | 002 | Garzulys | 351(k) Biosimilar | Rx | Emerge Bioscience Pte. Ltd. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-07-01 | 001 | Garzulys | 351(k) Biosimilar | Rx | Licensed | 2026-07-24 |
| 2026-07-01 | 002 | Garzulys | 351(k) Biosimilar | Rx | Licensed | 2026-07-24 |