FDA.reportPublic FDA data

Application 207831

Type
ANDA
Sponsor
GLAND PHARMA LTD

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
68083-386ClofarabineClofarabineGland Pharma LimitedANDACurrent
68083-386ClofarabineClofarabineGland Pharma LimitedANDACurrent
68083-386ClofarabineClofarabineGland Pharma LimitedANDACurrent
68083-386ClofarabineClofarabineGland Pharma LimitedANDACurrent
72266-108CLOFARABINECLOFARABINEFosun Pharma USA Inc.ANDACurrent
72266-108CLOFARABINECLOFARABINEFosun Pharma USA Inc.ANDACurrent