Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Accenture
Johnson and Johnson
Daiichi Sankyo
Healthtrust
Queensland Health
Cantor Fitzgerald
Farmers Insurance
Express Scripts

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017836

« Back to Dashboard

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
Tradename:JEANATOPE
Applicant:Iso Tex
Ingredient:albumin iodinated i-125 serum
Patents:0
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 N 50914-7732-5

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Accenture
Chubb
US Army
Deloitte
McKesson
Harvard Business School
Daiichi Sankyo
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.