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Zymfentra
infliximab-dyyb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zymfentra
Proper name
infliximab-dyyb
Licence type
351(a)
BLA number
761358
Applicant
CELLTRION, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 20, 2023 |
| 120MG/ML | Injection | Subcutaneous | Autoinjector | Rx | October 20, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |