FDA.reportPublic FDA data

Application 210046

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION500MG/VIALNoNo
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION1GM/VIALNoNo
003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEINJECTABLE;INJECTION2GM/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68001-370CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-370CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-370CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-371CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-371CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-371CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-372CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-372CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
68001-372CyclophosphamideCyclophosphamideBluePoint LaboratoriesANDACurrent
70121-1238CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1238CyclophosphamideCyclophosphamideAmneal Biosciences LLCANDACurrent
70121-1238CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1238CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1238CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1239CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1239CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1239CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1239CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1239CyclophosphamideCyclophosphamideAmneal Biosciences LLCANDACurrent
70121-1240CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1240CyclophosphamideCyclophosphamideAmneal Biosciences LLCANDACurrent
70121-1240CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1240CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
70121-1240CyclophosphamideCyclophosphamideAmneal Pharmaceuticals LLCANDACurrent
72603-104CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-104CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-104CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-104CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-104CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-326CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-326CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-326CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-326CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-326CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-411CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-411CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-411CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-411CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent
72603-411CyclophosphamideCyclophosphamideNorthStar RxLLCANDACurrent