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Papzimeos
zopapogene imadenovec-drba
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Papzimeos
Proper name
zopapogene imadenovec-drba
Licence type
351(a)
BLA number
125832
Applicant
Precigen, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 5x10^11PARTICLE UNITS | For Injection | Subcutaneous | Single-Dose Vial | Rx | August 14, 2025 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 14, 1932 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |