FDA.reportPublic FDA data

Application 091356

Type
ANDA
Sponsor
STRIDES PHARMA

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
17856-0723CalcitriolCalcitriol 0.25 mcgAtlantic Biologicals CorpsANDACurrent
23155-662CALCITRIOLCALCITRIOLAvet Pharmaceuticals Inc.ANDACurrent
23155-662CALCITRIOLCALCITRIOLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-662CALCITRIOLCALCITRIOLHeritage Pharmaceuticals Inc.ANDACurrent
23155-663CALCITRIOLCALCITRIOLAvet Pharmaceuticals Inc.ANDACurrent
23155-663CALCITRIOLCALCITRIOLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-663CALCITRIOLCALCITRIOLHeritage Pharmaceuticals Inc.ANDACurrent
55154-8186CalcitriolCalcitriol Capsules 0.25 mcgCardinal HealthANDACurrent
55154-8186CalcitriolCalcitriol Capsules 0.25 mcgCardinal Health 107, LLCANDACurrent
60687-345CalcitriolCalcitriol Capsules 0.25 mcgAmerican Health PackagingANDACurrent
60687-345CalcitriolCalcitriol Capsules 0.25 mcgAmerican Health PackagingANDACurrent
60687-345CalcitriolCalcitriol Capsules 0.25 mcgAmerican Health PackagingANDACurrent
64380-723CalcitriolCalcitriol Capsules 0.25 mcgStrides Pharma Science LimitedANDACurrent
64380-723CalcitriolCalcitriol Capsules 0.25 mcgStrides Shasun LimitedANDACurrent
64380-723CalcitriolCalcitriol Capsules 0.25 mcgStrides Pharma Science LimitedANDACurrent
64380-723CalcitriolCalcitriol Capsules 0.25 mcgStrides Pharma Science LimitedANDACurrent
64380-724CalcitriolCalcitriol Capsules 0.5 mcgStrides Pharma Science LimitedANDACurrent
64380-724CalcitriolCalcitriol Capsules 0.5 mcgStrides Shasun LimitedANDACurrent
64380-724CalcitriolCalcitriol Capsules 0.5 mcgStrides Pharma Science LimitedANDACurrent
64380-724CalcitriolCalcitriol Capsules 0.5 mcgStrides Pharma Science LimitedANDACurrent