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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216748


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NDA 216748 describes DEXRAZOXANE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland, Hikma, and MSN, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the DEXRAZOXANE HYDROCHLORIDE profile page.

The generic ingredient in DEXRAZOXANE HYDROCHLORIDE 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 216748
Tradename:DEXRAZOXANE HYDROCHLORIDE
Applicant:Msn
Ingredient:dexrazoxane hydrochloride
Patents:0
Pharmacology for NDA: 216748
Medical Subject Heading (MeSH) Categories for 216748
Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors
Suppliers and Packaging for NDA: 216748
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 216748 ANDA Novadoz Pharmaceuticals LLC 72205-247 72205-247-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-247-01) / 25 mL in 1 VIAL, SINGLE-DOSE
DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 216748 ANDA Novadoz Pharmaceuticals LLC 72205-248 72205-248-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Mar 26, 2025TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Mar 26, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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