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NeutroSpec
technetium 99m tc fanolesomab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
NeutroSpec
Proper name
technetium 99m tc fanolesomab
Licence type
351(a)
BLA number
103928
Applicant
Palatin Technologies, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.25MG | Injection | Intravenous | Single-Dose Vial | Disc | July 2, 2004 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |