FDA.reportPublic FDA data

Application 206228

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE;INJECTION1MG/MLNoNo
002ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE;INJECTION2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49315-005Arsenic trioxideArsenic trioxideCadila Healthcare LimitedANDACurrent
49315-005Arsenic trioxideArsenic trioxideAlidac Pharmaceuticals LimitedANDACurrent
49315-005Arsenic trioxideArsenic trioxideZydus Lifesciences LimitedANDACurrent
49315-007Arsenic trioxideArsenic trioxideAlidac Pharmaceuticals LimitedANDACurrent
49315-007Arsenic trioxideArsenic trioxideCadila Healthcare LimitedANDACurrent
49315-007Arsenic trioxideArsenic trioxideZydus Lifesciences LimitedANDACurrent
68382-997Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-997Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-997Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-997Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-997Arsenic trioxideArsenic trioxideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1610Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1610Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1610Arsenic trioxideArsenic trioxideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1610Arsenic trioxideArsenic trioxideZydus Pharmaceuticals USA Inc.ANDACurrent