FDA.reportPublic FDA data

Application 076242

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCITRIOLCALCITRIOLSOLUTION;ORAL1MCG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3120CalcitriolCalcitriolHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3120CalcitriolCalcitriolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3120CalcitriolCalcitriolWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3120CalcitriolCalcitriolHikma Pharmaceuticals USA Inc.ANDACurrent
17856-3120CalcitriolCalcitriolATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3120CalcitriolCalcitriolATLANTIC BIOLOGICALS CORP.ANDACurrent