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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 017279


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NDA 017279 describes GLOFIL-125, which is a drug marketed by Isotex and is included in one NDA. It is available from one supplier. Additional details are available on the GLOFIL-125 profile page.

The generic ingredient in GLOFIL-125 is iothalamate sodium i-125. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate sodium i-125 profile page.
Summary for 017279
Tradename:GLOFIL-125
Applicant:Isotex
Ingredient:iothalamate sodium i-125
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017279
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 017279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLOFIL-125 iothalamate sodium i-125 INJECTABLE;INJECTION 017279 NDA Iso-Tex Diagnostics, Inc. 50914-7729 50914-7729-2 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) > 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250-300uCi/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
McKinsey
Baxter
AstraZeneca
Colorcon

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