FDA.reportPublic FDA data

Application 213278

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION40MG/2ML (20MG/ML)NoNo
002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION100MG/5ML (20MG/ML)NoNo
003IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION300MG/15ML (20MG/ML)NoNo
004IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-352IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-352IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-353IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-353IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-354IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-354IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-355IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent