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Andembry
garadacimab-gxii
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Andembry
Proper name
garadacimab-gxii
Licence type
351(a)
BLA number
761367
Applicant
CSL Behring LLC
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200MG/1.2ML (167MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | June 16, 2025 |
| 200MG/1.2ML (167MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 16, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |