FDA.reportPublic FDA data

Application 205487

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
002CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS150MG/15ML (10MG/ML)NoNo
003CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS450MG/45ML (10MG/ML)NoNo
004CARBOPLATINCARBOPLATININJECTABLE;INJECTION600MG/60ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-333CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-333CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-334CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-334CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-335CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-335CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
55150-386CARBOPLATINCARBOPLATINAuroMedics Pharma LLCANDACurrent
57277-105Carboplatincarboplatin InjectionSanja Pharmaceuticals CompanyANDACurrent
57277-106Carboplatincarboplatin InjectionSanja Pharmaceuticals CompanyANDACurrent
57277-107Carboplatincarboplatin InjectionSanja Pharmaceuticals CompanyANDACurrent