FDA.reportPublic FDA data

Application 204880

Type
ANDA
Sponsor
ACTAVIS LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-637OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-637OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-638OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-638OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent