FDA.reportPublic FDA data

Application 204029

Type
ANDA
Sponsor
ABON PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOFARABINECLOFARABINESOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49315-003CLOFARABINEclofarabineCadila Healthcare LimitedANDACurrent
49315-003CLOFARABINEclofarabineZydus Lifesciences LimitedANDACurrent
63323-572CLOFARABINEclofarabineFresenius-KabiANDACurrent
63323-572CLOFARABINEclofarabineFresenius Kabi USA, LLCANDACurrent
63323-572CLOFARABINEclofarabineFresenius-KabiANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48375ORIG2017-05-15
48366ORIG2017-05-12