Application 017835
- Type
- BLA
- Sponsor
- ISO TEX
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 017835 | Chromalbin | albumin chromated CR-51 serum | 351(a) | Disc | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | INJECTABLE;INJECTION | 100uCi/VIAL | No | No |
| 002 | CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | INJECTABLE;INJECTION | 250uCi/VIAL | No | No |
| 003 | CHROMALBIN | ALBUMIN CHROMATED CR-51 SERUM | INJECTABLE;INJECTION | 500uCi/VIAL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66356 | APPL | 2020-03-23 |