FDA.reportPublic FDA data

Application 210735

Type
NDA
Sponsor
AUROMEDICS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDESOLUTION;INTRAVENOUS500MG/2.5ml (200MG/ML)YesNo
002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDESOLUTION;INTRAVENOUS1GM/5ML (200MG/ML)YesNo
003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDESOLUTION;INTRAVENOUS2GM/10ML (200MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-270CyclophosphamideCyclophosphamideAuroMedics Pharma LLCNDACurrent
55150-270CyclophosphamideCyclophosphamideAuroMedics Pharma LLCNDACurrent
55150-271CyclophosphamideCyclophosphamideAuroMedics Pharma LLCNDACurrent
55150-271CyclophosphamideCyclophosphamideAuroMedics Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76670ORIG 2023-11-28
76644SUPPL 2023-11-21
76637SUPPL 2023-11-21
70814ORIG2022-04-26
68480ORIG2021-08-27