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Jeanatope

iodinated I-125 albumin

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Jeanatope
Proper name
iodinated I-125 albumin
Licence type
351(a)
BLA number
017836
Applicant
Iso-Tex Diagnostics, Inc.
Center
CDER
Presentations
3
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1,000uCi/ML (1,000uCi/ML) Injection Intravenous Multi-Dose Vial Disc February 23, 1976
100uCi/10ML (10uCi/ML) Injection Intravenous Multi-Dose Vial Disc June 8, 2004
500uCi/0.5ML (1,000uCi/ML) Injection Intravenous Multi-Dose Vial Disc February 23, 1976

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity