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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022025

TOTECT (DEXRAZOXANE HYDROCHLORIDE)
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEXRAZOXANE HYDROCHLORIDE
Proprietary Name: TOTECT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022025
Product Number: 001
Approval Date: Sep 6, 2007
Applicant Holder Full Name: CLINIGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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