FDA.reportPublic FDA data

Application 207453

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL5MGNoNo
002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL10MGNoNo
003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL20MGNoNo
004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-043Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-043Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-043Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-043Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-044Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-044Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-044Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-044Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-045Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-045Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-045Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-045Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-046Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-046Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-046Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent
71209-046Rosuvastatin CalciumRosuvastatin CalciumCadila Pharmaceuticals LimitedANDACurrent