APPLICATION
ANDA200752
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-19
LATEST ACTION
2015-05-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXRAZOXANE HYDROCHLORIDEPrescription
DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL · INJECTABLE · INJECTION
DEXRAZOXANE HYDROCHLORIDEPrescription
DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2015-05-19Labeling · Supplement 4 · standardAP
2015-05-19Labeling · Supplement 2 · standardAP
2011-10-19Not Applicable · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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