FDA.reportPublic FDA data

Application 201619

Type
ANDA
Sponsor
TORRENT

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
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6778Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6779Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6780Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
0904-6781Rosuvastatin CalciumRosuvastatin CalciumMajor PharmaceuticalsANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-179Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-180Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-181Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
13668-182Rosuvastatin CalciumRosuvastatin CalciumTorrent Pharmaceuticals LimitedANDACurrent
50090-4039Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4039Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4056Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-4056Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5116Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5116Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal Health 107, LLCANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
55154-8099Rosuvastatin CalciumRosuvastatin CalciumCardinal HealthANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
63629-7158Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3348Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3349Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent