FDA.reportPublic FDA data

Application 203929

Type
ANDA
Sponsor
AKORN INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-987DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-987DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-987DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-987DoxercalciferolDoxercalciferolAkornANDACurrent
17478-987DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-988DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-988DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-988DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent
17478-988DoxercalciferolDoxercalciferolAkornANDACurrent
17478-988DoxercalciferolDoxercalciferolAkorn, Inc.ANDACurrent