Application 083022

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DODEXCYANOCOBALAMININJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-533DODEX INJECTABLECYANOCOBALAMINAccord Healthcare, Inc.ANDACurrent
16729-533DODEX INJECTABLECYANOCOBALAMINAccord Healthcare, Inc.ANDACurrent
16729-533DODEX INJECTABLEcyanocobalaminAccord Healthcare, Inc.ANDACurrent