FDA.reportPublic FDA data

Application 040745

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-935CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-936CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-937CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-938CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-939CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-942CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-943CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-944CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-945CYCLOPHOSPHAMIDEcyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-955CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-956CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
10019-957CyclophosphamidecyclophosphamideBaxter Healthcare CorporationANDACurrent
68001-442CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
68001-443CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
68001-444CyclophosphamidecyclophosphamideBluePoint LaboratoriesANDACurrent
72572-083CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent
72572-085CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent
72572-087CyclophosphamidecyclophosphamideCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17786SUPPL2014-10-27
42636ORIG2012-03-27