Dexrazoxane
These highlights do not include all the information needed to use DEXRAZOXANE FOR INJECTION safely and effectively. See full prescribing information for DEXRAZOXANE FOR INJECTION. DEXRAZOXANE for Injection for [Route of Administration] use Initial U.S. Approval: 1995
Approved
Approval ID
68089182-d4a2-4053-8d0d-fc97a901515d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexrazoxane
PRODUCT DETAILS
NDC Product Code0143-9247
Application NumberANDA076068
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
Generic NameDexrazoxane
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Dexrazoxane
PRODUCT DETAILS
NDC Product Code0143-9248
Application NumberANDA076068
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
Generic NameDexrazoxane
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT