Application 021846
- Type
- BLA
- Sponsor
- MICROBIX BIOSYSTEMS
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 021846 | Kinlytic | urokinase | 351(a) | Disc | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KINLYTIC | UROKINASE | INJECTABLE;INJECTION | 250,000 IU/VIAL | No | No |
| 002 | KINLYTIC | UROKINASE | INJECTABLE;INJECTION | 9,000 IU/VIAL | No | No |
| 003 | KINLYTIC | UROKINASE | INJECTABLE;INJECTION | 5,000 IU/VIAL | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 37755 | SUPPL | 2020-03-23 |
| 37754 | SUPPL | 2020-03-23 |
| 28704 | SUPPL | 2020-03-23 |
| 6297 | SUPPL | 2020-03-23 |
| 6296 | SUPPL | 2020-03-23 |
| 66432 | APPL | 2020-03-22 |