Application 761042
- Type
- BLA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERELZI | ETANERCEPT-SZZS | INJECTABLE; INJECTION | 25MG/0.5ML | No | No |
| 002 | ERELZI | ETANERCEPT-SZZS | INJECTABLE; INJECTION | 50MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72612 | SUPPL | 2022-11-14 |
| 72608 | SUPPL | 2022-11-13 |
| 72607 | SUPPL | 2022-11-13 |
| 63497 | SUPPL | 2020-06-12 |
| 63496 | SUPPL | 2020-06-12 |
| 63492 | SUPPL | 2020-06-12 |
| 60622 | SUPPL | 2019-10-22 |
| 60612 | SUPPL | 2019-10-21 |
| 53730 | SUPPL | 2018-04-18 |
| 52133 | SUPPL | 2018-01-30 |
| 52085 | SUPPL | 2018-01-30 |
| 46042 | ORIG | 2016-12-06 |
| 45596 | ORIG | 2016-10-25 |
| 45124 | ORIG | 2016-08-30 |
| 45123 | ORIG | 2016-08-30 |
| 63226 | ORIG | 1900-01-01 |
| 52492 | ORIG | 1900-01-01 |
| 52491 | ORIG | 1900-01-01 |
| 52490 | ORIG | 1900-01-01 |