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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Argus Health
Farmers Insurance
Queensland Health

Generated: September 24, 2017

DrugPatentWatch Database Preview

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 six 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 NDA: 017836

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
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

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Johnson and Johnson
Farmers Insurance
US Army
Express Scripts

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