Proplex-T; Bebulin Purple Book BLA 103112
- BLA number
- 103112
- Proprietary names
- Proplex-T; Bebulin
- Proper names
- Factor IX Complex
- Applicant
- Baxalta US Inc.
- Center
- CBER
- First observed release
- 2022-05-01
- 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 | Proplex-T; Bebulin | Factor IX Complex | 351(a) | 200-1200U/20ML | For Injection | Intravenous | Vial | Rx | Voluntarily Revoked | 1970-08-21 | |
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 |
|---|
| 2022-05-01 | N | 001 | Proplex-T; Bebulin | 351(a) | Rx | Baxalta US Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-05-01 | 001 | Proplex-T; Bebulin | 351(a) | Rx | Voluntarily Revoked | 1970-08-21 |