FDA.reportPublic FDA data

Application 214575

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/2ML (10MG/ML)NoNo
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/8ML (10MG/ML)NoNo
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/16ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-378DocetaxelDocetaxelAuroMedics Pharma LLCANDACurrent
55150-379DocetaxelDocetaxelAuroMedics Pharma LLCANDACurrent
55150-380DocetaxelDocetaxelAuroMedics Pharma LLCANDACurrent