Mononine Purple Book BLA 103957
- BLA number
- 103957
- Proprietary names
- Mononine
- Proper names
- Coagulation Factor IX (Human)
- Applicant
- CSL Behring LLC
- Center
- CBER
- First observed release
- 2020-08-01
- 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 | Mononine | Coagulation Factor IX (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
| 002 | Mononine | Coagulation Factor IX (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2000-03-17 | |
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 |
|---|
| 2023-07-01 | U | 001 | Mononine | 351(a) | Disc | CSL Behring LLC |
| 2023-07-01 | U | 002 | Mononine | 351(a) | Disc | CSL Behring LLC |
| 2022-03-01 | U | 001 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2022-03-01 | U | 002 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2021-09-01 | U | 001 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2021-09-01 | U | 002 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2021-05-01 | U | 001 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2021-05-01 | U | 002 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2020-08-01 | R | 001 | Mononine | 351(a) | Rx | CSL Behring LLC |
| 2020-08-01 | R | 002 | Mononine | 351(a) | Rx | CSL Behring LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-07-01 | 001 | Mononine | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2023-07-01 | 002 | Mononine | 351(a) | Disc | Voluntarily Revoked | 2000-03-17 |
| 2022-03-01 | 001 | Mononine | 351(a) | Rx | Voluntarily Revoked | 2000-03-17 |
| 2022-03-01 | 002 | Mononine | 351(a) | Rx | Voluntarily Revoked | 2000-03-17 |
| 2020-08-01 | 001 | Mononine | 351(a) | Rx | Licensed | 2000-03-17 |
| 2020-08-01 | 002 | Mononine | 351(a) | Rx | Licensed | 2000-03-17 |