FDA.reportPublic FDA data

Application 012141

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYTOXANCYCLOPHOSPHAMIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CYTOXANCYCLOPHOSPHAMIDETABLET;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-982CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDA AUTHORIZED GENERICCurrent
10019-982CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDA AUTHORIZED GENERICCurrent
10019-982CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDA AUTHORIZED GENERICCurrent
10019-984CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDACurrent
10019-984CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDACurrent
10019-984CyclophosphamideCyclophosphamideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64446SUPPL2020-08-28
11989SUPPL2013-05-10
10793SUPPL2013-05-09
11988SUPPL2012-04-04
10792SUPPL2012-04-02
305SUPPL2003-03-10