Application 761244
- Type
- BLA
- Sponsor
- BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SPEVIGO | SPESOLIMAB-SBZO | INJECTABLE;INTRAVENOUS | 900MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0035 | SPEVIGO | spesolimab-sbzo | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83877 | SUPPL | 2025-10-23 |
| 83866 | SUPPL | 2025-10-22 |
| 83865 | SUPPL | 2025-10-22 |
| 82395 | SUPPL | 2025-06-02 |
| 82353 | SUPPL | 2025-05-29 |
| 82352 | SUPPL | 2025-05-29 |
| 77871 | SUPPL | 2024-03-19 |
| 77865 | SUPPL | 2024-03-19 |
| 72203 | ORIG | 2022-09-30 |
| 72009 | ORIG | 2022-09-02 |
| 72008 | ORIG | 2022-09-02 |
| 72001 | ORIG | 2022-09-02 |