FDA.reportPublic FDA data

Application 207408

Type
ANDA
Sponsor
CHANGZHOU PHARM

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
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-155Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-156Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-157Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
27808-158Rosuvastatin CalciumRosuvastatin CalciumTris Pharma IncANDACurrent
50090-6077Rosuvastatin CalciumRosuvastatin CalciumA-S Medication SolutionsANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-153Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-154Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-155Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
51407-156Rosuvastatin CalciumRosuvastatin CalciumGolden State Medical Supply, Inc.ANDACurrent
71205-390Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-390Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-475Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71205-475Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-0905Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71335-2055Rosuvastatin CalciumRosuvastatin CalciumBryant Ranch PrepackANDACurrent
71610-232Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-233Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-234Rosuvastatin CalciumRosuvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent