FDA.reportPublic FDA data

Application 207014

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDECAPSULE;ORAL25MGNoNo
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDECAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-307CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-307CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-307CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-307CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-308CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-308CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-308CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-308CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
62559-930CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent
62559-930CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent
62559-931CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent
62559-931CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53146ORIG2018-03-22