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Generated: May 25, 2019

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Details for New Drug Application (NDA): 017836

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NDA 017836 describes JEANATOPE, which is a drug marketed by Iso Tex and is included in one NDA. It is available from one supplier. Additional details are available on the JEANATOPE profile page.

The generic ingredient in JEANATOPE is albumin iodinated i-125 serum. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albumin iodinated i-125 serum profile page.
Summary for 017836
Applicant:Iso Tex
Ingredient:albumin iodinated i-125 serum
Formulation / Manufacturing:see details
Pharmacology for NDA: 017836
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 017836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JEANATOPE albumin iodinated i-125 serum INJECTABLE;INJECTION 017836 NDA Iso-Tex Diagnostics, Inc. 50914-7732 50914-7732-5 1 VIAL, MULTI-DOSE in 1 BOX (50914-7732-5) > 11 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500uCi/0.5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1,000uCi/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100uCi/10ML (10uCi/ML)
Approval Date:Jun 8, 2004TE:RLD:Yes

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