Application 018663
- Type
- BLA
- Sponsor
- CHART MEDCL
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 018663 | Chymodiactin | chymopapain | 351(a) | Disc | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHYMODIACTIN | CHYMOPAPAIN | INJECTABLE;INJECTION | 10,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | CHYMODIACTIN | CHYMOPAPAIN | INJECTABLE;INJECTION | 4,000 UNITS/VIAL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62256 | APPL | 2020-03-23 |