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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

Tradename:
1
Applicant:
1
Ingredient:
1
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 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
Moodys
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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.

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