FDA.reportPublic FDA data

Application 201518

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL0.5MCGNoNo
002DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL1MCGNoNo
003DOXERCALCIFEROLDOXERCALCIFEROLCAPSULE;ORAL2.5MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-228DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-228DOXERCALCIFEROLDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-228DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-229DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-229DOXERCALCIFEROLDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-229DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-230DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-230DOXERCALCIFEROLDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent
64980-230DoxercalciferolDoxercalciferolRising Pharmaceuticals, Inc.ANDACurrent