FDA.reportPublic FDA data

Application 205529

Type
ANDA
Sponsor
EUGIA PHARMA

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
55150-331OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
55150-331OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
55150-331OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
55150-332OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
55150-332OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
55150-332OxaliplatinOxaliplatinAuroMedics Pharma LLCANDACurrent
57277-001OxaliplatinOxaliplatinSanja Pharmaceuticals CompanyANDACurrent
57277-002OxaliplatinOxaliplatinSanja Pharmaceuticals CompanyANDACurrent