Product Details for: Jeanatope
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
500uCi/0.5ML (1,000uCi/ML)
Multi-Dose Vial
351(a)
Jeanatope
Disc
002
Injection
Intravenous
1,000uCi/ML (1,000uCi/ML)
Multi-Dose Vial
351(a)
Jeanatope
Disc
003
Injection
Intravenous
100uCi/10ML (10uCi/ML)
Multi-Dose Vial
351(a)
Jeanatope
Disc
Proper Name
iodinated I-125 albumin
iodinated I-125 albumin
BLA Number
017836
017836
Applicant
Iso-Tex Diagnostics, Inc.
Iso-Tex Diagnostics, Inc.
Original Approval Date
February 23, 1976
February 23, 1976
Date of First Licensure