Application 761224
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761224 | Tezspire | tezepelumab-ekko | 351(a) | Rx | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEZSPIRE | TEZEPELUMAB-EKKO | SOLUTION;SUBCUTANEOUS | 210MG/1.91ML(110MG/ML) | No | No |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TEZSPIRE | TEZEPELUMAB-EKKO | Amgen Inc | 60f0aa03-ad25-4d48-80ce-7fcfa76f325f | 2025-10-17 | Warnings, Adverse reactions | BLA761224 55513-100 55513-112 |
NDC Listings For This Application#
| 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 |