Application 208523

Type
ANDA
Sponsor
CIPLA

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
16714-727oxaliplatinoxaliplatinNorthStar RxLLCANDACurrent
16714-727oxaliplatinoxaliplatinNorthStar RxLLCANDACurrent
16714-728oxaliplatinoxaliplatinNorthStar RxLLCANDACurrent
16714-728oxaliplatinoxaliplatinNorthStar RxLLCANDACurrent
68001-341oxaliplatinoxaliplatinBluePoint LaboratoriesANDACurrent
69097-274oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent
69097-274oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent
69097-274oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent
69097-353oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent
69097-353oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent
69097-353oxaliplatinoxaliplatinCipla USA Inc.ANDACurrent