FDA.reportPublic FDA data

Application 075765

Type
ANDA
Sponsor
TEVA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7352CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7352CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7352CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7353CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7353CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7353CalcitriolCalcitriolTeva Pharmaceuticals USA, Inc.ANDACurrent
0179-0245CalcitriolCalcitriolKAISER FOUNDATION HOSPITAANDACurrent
63629-8741CalcitriolCalcitriolBryant Ranch PrepackANDACurrent
63629-8741CalcitriolCalcitriolBryant Ranch PrepackANDACurrent
63629-8742CalcitriolCalcitriolBryant Ranch PrepackANDACurrent
63629-8742CalcitriolCalcitriolBryant Ranch PrepackANDACurrent
71335-1594CalcitriolCalcitriolBryant Ranch PrepackANDACurrent
71335-2095CalcitriolCalcitriolBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31012ORIG2003-04-15