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Tezspire
tezepelumab-ekko
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tezspire
Proper name
tezepelumab-ekko
Licence type
351(a)
BLA number
761224
Applicant
AstraZeneca AB
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | December 17, 2021 |
| 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | December 17, 2021 |
| 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | February 1, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |