Application 125561
- Type
- BLA
- Sponsor
- ALEXION PHARM
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125561 | Kanuma | sebelipase alfa | 351(a) | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KANUMA | SEBELIPASE ALFA | INJECTABLE;INJECTION | 20MG/10ML | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 4 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25682-007 | KANUMA | Sebelipase alfa | Alexion Pharmaceuticals, Inc. | BLA | Current |
| 25682-007 | KANUMA | Sebelipase alfa | Alexion Pharmaceuticals, Inc. | BLA | Current |
| 25682-007 | KANUMA | Sebelipase alfa | Alexion Pharmaceuticals, Inc. | BLA | Current |
| 25682-007 | KANUMA | Sebelipase alfa | Alexion Pharmaceuticals, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79079 | SUPPL | 2024-07-15 |
| 79046 | SUPPL | 2024-07-11 |
| 69384 | SUPPL | 2021-11-23 |
| 69365 | SUPPL | 2021-11-22 |
| 22825 | ORIG | 2016-01-06 |
| 18938 | ORIG | 2015-12-08 |
| 9788 | ORIG | 2015-12-08 |