FDA.reportPublic FDA data

Application 200752

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 250MG BASE/VIALNoNo
002DEXRAZOXANE HYDROCHLORIDEDEXRAZOXANE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-434DEXRAZOXANEDEXRAZOXANEAuroMedics Pharma LLCANDACurrent
55150-434DEXRAZOXANEDEXRAZOXANEAuroMedics Pharma LLCANDACurrent
55150-437DEXRAZOXANEDEXRAZOXANEAuroMedics Pharma LLCANDACurrent
67457-207Dexrazoxane HydrochloridedexrazoxaneMylan Institutional LLCANDACurrent
67457-208Dexrazoxane HydrochloridedexrazoxaneMylan Institutional LLCANDACurrent