FDA.reportPublic FDA data

Application 208898

Type
ANDA
Sponsor
MSN

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
50090-5110Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5770Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
61919-786RosuvastatinRosuvastatinDirect_RxANDACurrent
61919-786RosuvastatinRosuvastatinDirect_RxANDACurrent
61919-799ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUNDIRECT RXANDACurrent
61919-799ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUNDIRECT RXANDACurrent
68071-2378Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2379Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4764Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4764Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4896Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4896Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4896Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4896Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5176Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5176Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5176Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5225Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5225Rosuvastatin CalciumRosuvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7310Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7310Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7310Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7566Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7566Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7612Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7612Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7612Rosuvastatin CalciumRosuvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
69539-007Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-007Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-007Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-008Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-008Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-008Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-009Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-009Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-009Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-010Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-010Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-010Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-160Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-160Rosuvastatin CalciumRosuvastatin CalciumMSN LABORATORIES PRIVATE LIMITEDANDACurrent
70518-1726Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1726Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1819Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2055Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2055Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2055Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2055Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2055Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2090Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2090Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2090Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2542Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2542Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2542Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2774Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2774Rosuvastatin CalciumRosuvastatin CalciumREMEDYREPACK INC.ANDACurrent
70934-244Rosuvastatin CalciumRosuvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-244Rosuvastatin CalciumRosuvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-245Rosuvastatin CalciumRosuvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-245Rosuvastatin CalciumRosuvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-399Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71335-1017Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1017Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1017Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1017Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1017Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1098Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1098Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1098Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1103Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1103Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1103Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1330Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1330Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent