FDA.reportPublic FDA data

Application 206465

Type
ANDA
Sponsor
ALKEM LABS 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
50090-5188Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5188Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5188Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5188Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5188Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5189Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5468Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
51655-987Rosuvastatin CalciumRosuvastatin CalciumNorthwind PharmaceuticalsANDACurrent
67877-439Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-439Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-439Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-439Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-439Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-440Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-440Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-440Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-440Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-440Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-441Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-441Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-441Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-441Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-441Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-442Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-442Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-442Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-442Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
67877-442Rosuvastatin CalciumRosuvastatin CalciumAscend Laboratories, LLCANDACurrent
68071-2407Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7947Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7947Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
71335-2035Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent