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Draximage MAA
kit for the preparation of technetium Tc-99m albumin aggregated
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Draximage MAA
Proper name
kit for the preparation of technetium Tc-99m albumin aggregated
Licence type
351(a)
BLA number
017881
Applicant
Jubilant DraxImage Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2.5MG/5MG/0.6MG/ 1.2MG | For Injectable Suspension | Intravenous | Multi-Dose Vial | Rx | December 30, 1987 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |