FDA.reportPublic FDA data

Application 076917

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0007CalcitriolCalcitriolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0007CalcitriolCalcitriolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0007CalcitriolCalcitriolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0007CalcitriolCalcitriolWest-Ward Pharmaceuticals Corp.ANDACurrent
43353-034CalcitriolCalcitriolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-034CalcitriolCalcitriolAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-521CalcitriolCalcitriolAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-058CalcitriolCalcitriolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-058CalcitriolCalcitriolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-058CalcitriolCalcitriolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-058CalcitriolCalcitriolPD-Rx Pharmaceuticals, Inc.ANDACurrent