FDA.reportPublic FDA data

Application 203856

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDECAPSULE;ORAL25MGYesNo
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDECAPSULE;ORAL50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0382CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0382CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0382CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0383CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0383CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent
0054-0383CyclophosphamideCyclophosphamideWest-Ward Pharmaceuticals Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60214SUPPL2019-10-03
60143SUPPL2019-09-27
43446ORIG2014-03-06
24451ORIG2014-03-06
10254ORIG2013-09-19
40329ORIG2013-09-18