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Megatope
iodinated I-131 albumin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Megatope
Proper name
iodinated I-131 albumin
Licence type
351(a)
BLA number
017837
Applicant
Iso-Tex Diagnostics, Inc.
Center
CDER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5mCi | Injection | Intravenous | Multi-Dose Vial | Disc | February 23, 1976 |
| 1mCi | Injection | Intravenous | Multi-Dose Vial | Rx | February 23, 1976 |
| 20uCi/AMP | Injection | Intravenous | Multi-Dose Vial | Disc | February 23, 1976 |
| 2mCi | Injection | Intravenous | Multi-Dose Vial | Disc | February 23, 1976 |
| 5uCi/AMP | Injection | Intravenous | Multi-Dose Vial | Disc | February 23, 1976 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |