FDA.reportPublic FDA data

Application 204368

Type
ANDA
Sponsor
QILU

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)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6132OxaliplatinOxaliplatinApotex Corp.ANDACurrent
60505-6132OxaliplatinOxaliplatinApotex Corp.ANDACurrent
60505-6132oxaliplatinoxaliplatinApotex Corp.ANDACurrent
60505-6132OxaliplatinOxaliplatinApotex Corp.ANDACurrent
60505-6132oxaliplatinoxaliplatinApotex Corp.ANDACurrent
60505-6132OxaliplatinOxaliplatinApotex Corp.ANDACurrent
67184-0508OxaliplatinoxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0508OxaliplatinoxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0509OxaliplatinoxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0509OxaliplatinoxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0510OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0510OxaliplatinoxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
68001-468OxaliplatinOxaliplatinBluePoint LaboratoriesANDACurrent
68001-468OxaliplatinOxaliplatinBluePoint LaboratoriesANDACurrent
68001-468OxaliplatinOxaliplatinBluePoint LaboratoriesANDACurrent