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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
Deloitte
Fish and Richardson
US Department of Justice
Argus Health
Federal Trade Commission
Farmers Insurance
Healthtrust
Mallinckrodt

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022025

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NDA 022025 describes TOTECT, which is a drug marketed by Clinigen Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TOTECT profile page.

The generic ingredient in TOTECT is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 022025
Tradename:TOTECT
Applicant:Clinigen Hlthcare
Ingredient:dexrazoxane hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022025
Medical Subject Heading (MeSH) Categories for 022025
Suppliers and Packaging for NDA: 022025
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOTECT dexrazoxane hydrochloride INJECTABLE;INJECTION 022025 NDA Cumberland Pharmaceuticals Inc. 66220-110 66220-110-01 1 VIAL, SINGLE-USE in 1 CARTON (66220-110-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 6, 2007TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Mar 13, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Chubb
Moodys
Cerilliant
Mallinckrodt
Teva
QuintilesIMS
Fish and Richardson

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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