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Anavip
Crotalidae Immune F(ab')2 (Equine)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Anavip
Proper name
Crotalidae Immune F(ab')2 (Equine)
Licence type
351(a)
BLA number
125488
Applicant
Rare Disease Therapeutics, Inc. (RDT)
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Rx | May 6, 2015 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 6, 2022 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |