FDA.reportPublic FDA data

Application 202922

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/10ML (5MG/ML)NoNo
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/20ML (5MG/ML)NoNo
003OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS200MG/40ML (5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-046OxaliplatinOxaliplatinSun Pharmaceutical Industries, Inc.ANDACurrent
47335-047OxaliplatinOxaliplatinSun Pharmaceutical Industries, Inc.ANDACurrent