FDA.reportPublic FDA data

Application 078803

Type
ANDA
Sponsor
ACTAVIS TOTOWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/VIALNoYes
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-611OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-611OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-611OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-611OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent
45963-611OxaliplatinOxaliplatinActavis Pharma, Inc.ANDACurrent