Product Details for: Megatope

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
0.5mCi
Multi-Dose Vial
351(a)
Megatope
Disc
002
Injection
Intravenous
1mCi
Multi-Dose Vial
351(a)
Megatope
Rx
003
Injection
Intravenous
2mCi
Multi-Dose Vial
351(a)
Megatope
Disc
004
Injection
Intravenous
5uCi/AMP
Multi-Dose Vial
351(a)
Megatope
Disc
005
Injection
Intravenous
20uCi/AMP
Multi-Dose Vial
351(a)
Megatope
Disc
Proper Name
iodinated I-131 albumin
BLA Number
017837
Applicant
Iso-Tex Diagnostics, Inc.
Original Approval Date
February 23, 1976
Date of First Licensure
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