FDA.reportPublic FDA data

Application 203289

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCITRIOLCALCITRIOLCAPSULE;ORAL0.5MCGNoNo
002CALCITRIOLCALCITRIOLCAPSULE;ORAL0.25MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-519CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-519CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-519CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-519CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-576CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-576CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-576CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent
65162-576CalcitriolCalcitriolAmneal Pharmaceuticals LLCANDACurrent