FDA.reportPublic FDA data

Application 217651

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77849ORIG 2024-03-18
76764ORIG 2023-12-12
74646ORIG 2023-06-28