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ProstaScint
capromab pendetide
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
ProstaScint
Proper name
capromab pendetide
Licence type
351(a)
BLA number
103608
Applicant
Aytu BioScience, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5MG/1ML | Injection | Intravenous | Single-Dose Vial | Disc | October 28, 1996 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |