FDA.reportPublic FDA data

Application 206434

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-284ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-284Rosuvastatin calciumRosuvastatin calciumAccord Healthcare Inc.ANDACurrent
16729-284RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-284RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-284RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-284RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-285ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-285RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-285RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-285RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-285RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-285Rosuvastatin calciumRosuvastatin calciumAccord Healthcare Inc.ANDACurrent
16729-286RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-286RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-286RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-286RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-286ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-286Rosuvastatin calciumRosuvastatin calciumAccord Healthcare Inc.ANDACurrent
16729-287Rosuvastatin calciumRosuvastatin calciumAccord Healthcare Inc.ANDACurrent
16729-287ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-287RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-287RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-287RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
16729-287RosuvastatinRosuvastatinAccord Healthcare Inc.ANDACurrent
45865-894Rosuvastatin calciumRosuvastatin calciummedsource pharmaceuticalsANDACurrent
50090-3176Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
50090-3177Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
50090-3177Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
50090-3177Rosuvastatin calciumROSUVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
50090-3177Rosuvastatin calciumRosuvastatinA-S Medication SolutionsANDACurrent
50090-3437Rosuvastatin calciumROSUVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
50090-3437Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
50090-3706Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
50090-3706Rosuvastatin calciumRosuvastatin calciumA-S Medication SolutionsANDACurrent
53217-348Rosuvastatin calciumRosuvastatin calciumAidarex Pharmaceuticals LLCANDACurrent
55700-978RosuvastatinRosuvastatinQuality Care Products, LLCANDACurrent
61919-712ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
61919-712ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
63629-8124Rosuvastatin calciumRosuvastatin calciumBryant Ranch PrepackANDACurrent
63629-8124Rosuvastatin calciumRosuvastatin calciumBryant Ranch PrepackANDACurrent
68071-2816RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2885RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4765Rosuvastatin calciumRosuvastatin calciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4765Rosuvastatin calciumRosuvastatin calciumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6955Rosuvastatin calciumRosuvastatin calciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-6955Rosuvastatin calciumRosuvastatin calciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7086Rosuvastatin calciumRosuvastatin calciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7086Rosuvastatin calciumRosuvastatin calciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7086Rosuvastatin calciumRosuvastatin calciumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7971RosuvastatinRosuvastatinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7971RosuvastatinRosuvastatinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0375Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0375ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-0375ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-0375ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-0404Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0484Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0484Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0484Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-1169Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-1169Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-1311Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-1311Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-1311Rosuvastatin calciumRosuvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-3519RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-3519RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70934-275Rosuvastatin calciumRosuvastatin calciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-275Rosuvastatin calciumRosuvastatin calciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-275Rosuvastatin CalciumRosuvastatin CalciumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-008Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-008Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-008Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-008Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-099Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-099Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-099Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-099Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-176Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-176Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent
71205-176Rosuvastatin calciumRosuvastatin calciumProficient Rx LPANDACurrent