FDA.reportPublic FDA data

Application 213717

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXERCALCIFEROLDOXERCALCIFEROLINJECTABLE;INJECTION2MCG/ML (2MCG/ML)NoNo
002DOXERCALCIFEROLDOXERCALCIFEROLINJECTABLE;INJECTION4MCG/2ML (2MCG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-357DoxercalciferolDoxercalciferolAuroMedics Pharma LLCANDACurrent
55150-358DoxercalciferolDoxercalciferolAuroMedics Pharma LLCANDACurrent
55150-359DoxercalciferolDoxercalciferolAuroMedics Pharma LLCANDACurrent