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Generated: May 25, 2019

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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. Eight suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 022025
Applicant:Clinigen Hlthcare
Ingredient:dexrazoxane hydrochloride
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:➤ Try a Free TrialPatent Expiration:Mar 13, 2020Product Flag?Substance Flag?Delist Request?

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