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Microlite
radiolabeled albumin technetium Tc-99m albumin colloid kit
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Microlite
Proper name
radiolabeled albumin technetium Tc-99m albumin colloid kit
Licence type
351(a)
BLA number
018263
Applicant
Pharmalucence Inc
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| — | — | — | Single-Dose Vial | Disc | March 25, 1983 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |