Application 203313
- Type
- BLA
- Sponsor
- NOVO
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 203313 | Ryzodeg 70/30 | insulin degludec and insulin aspart | 351(a) | Disc | 2026-07-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYZODEG 70/30 | INSULIN ASPART; INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72294 | SUPPL | 2022-10-11 |
| 72273 | SUPPL | 2022-10-07 |
| 62409 | APPL | 2020-04-01 |
| 60949 | SUPPL | 2020-03-23 |
| 60948 | SUPPL | 2020-03-23 |
| 60878 | SUPPL | 2020-03-23 |
| 60877 | SUPPL | 2020-03-23 |
| 55156 | SUPPL | 2020-03-23 |
| 55148 | SUPPL | 2020-03-23 |
| 51191 | ORIG | 2020-03-23 |
| 51190 | ORIG | 2020-03-23 |
| 51187 | ORIG | 2020-03-23 |
| 46474 | SUPPL | 2020-03-23 |
| 46224 | SUPPL | 2020-03-23 |
| 40287 | SUPPL | 2020-03-23 |
| 32408 | ORIG | 2020-03-23 |
| 22920 | ORIG | 2020-03-23 |
| 19453 | ORIG | 2020-03-23 |
| 63074 | ORIG | 1900-01-01 |
| 63073 | ORIG | 1900-01-01 |
| 63072 | ORIG | 1900-01-01 |
| 63071 | ORIG | 1900-01-01 |