FDA.reportPublic FDA data

Application 207321

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
47781-578DexrazoxaneDexrazoxane for InjectionAlvogen Inc.ANDACurrent
51991-942DexrazoxaneDexrazoxane HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-942DexrazoxaneDexrazoxane HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
68083-195DexrazoxaneDexrazoxane for InjectionGland Pharma LimitedANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-101DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-235DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72266-235DexrazoxaneDexrazoxane for InjectionFosun Pharma USA Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent
72611-716DexrazoxaneDexrazoxane for InjectionAlmaject, Inc.ANDACurrent