Application Nr Approved Date Route Status External Links
ANDA200752 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dexrazoxane For Injection Is Indicated For Reducing The Incidence And Severity Of Cardiomyopathy Associated With Doxorubicin Administration In Women With Metastatic Breast Cancer Who Have Received A Cumulative Doxorubicin Dose Of 300 Mg/m 2 And Who Will Continue To Receive Doxorubicin Therapy To Maintain Tumor Control. Do Not Use With The Initiation Of Doxorubicin Therapy [See Warnings And Precautions (5.2) ] . Dexrazoxane For Injection Is A Cytoprotective Agent Indicated For Reducing The Incidence And Severity Of Cardiomyopathy Associated With Doxorubicin Administration In Women With Metastatic Breast Cancer Who Have Received A Cumulative Doxorubicin Dose Of 300 Mg/m 2 And Who Will Continue To Receive Doxorubicin Therapy To Maintain Tumor Control. Do Not Use Dexrazoxane For Injection With Doxorubicin Initiation. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dexrazoxane DEXRAZOXANE ZINC87515509

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