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Application 761224
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEZSPIRE | TEZEPELUMAB-EKKO | SOLUTION;SUBCUTANEOUS | 210MG/1.91ML(110MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55513-100 | TEZSPIRE | tezepelumab-ekko | Amgen, Inc | BLA | Current |
| 55513-100 | TEZSPIRE | tezepelumab-ekko | Amgen, Inc | BLA | Current |
| 55513-112 | TEZSPIRE | tezepelumab-ekko | Amgen, Inc | BLA | Current |
| 55513-112 | TEZSPIRE | tezepelumab-ekko | Amgen, Inc | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83860 | SUPPL | 2025-10-21 |
| 83817 | SUPPL | 2025-10-20 |
| 74403 | SUPPL | 2023-05-30 |
| 74399 | SUPPL | 2023-05-30 |
| 73445 | SUPPL | 2023-02-09 |
| 73366 | SUPPL | 2023-02-02 |
| 69865 | ORIG | 2022-01-13 |
| 69726 | ORIG | 2021-12-21 |
| 69627 | ORIG | 2021-12-17 |