FDA.reportPublic FDA data

Application 207616

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-882RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-882RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-883RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-883RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-884RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-884RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-885RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-885RosuvastatinRosuvastatinCamber Pharmaceuticals, Inc.ANDACurrent
50090-2722RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2723RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2724RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-2725RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50090-4909RosuvastatinRosuvastatinA-S Medication SolutionsANDACurrent
50268-709RosuvastatinRosuvastatinAvPAKANDACurrent
50268-709RosuvastatinRosuvastatinAvPAKANDACurrent
50268-710RosuvastatinRosuvastatinAvPAKANDACurrent
50268-710RosuvastatinRosuvastatinAvPAKANDACurrent
50268-711RosuvastatinRosuvastatinAvPAKANDACurrent
50268-711RosuvastatinRosuvastatinAvPAKANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA QuaANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-574RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-575RosuvastatinRosuvastatinQuality Care Products, LLCANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-575RosuvastatinRosuvastatinQuality Care Products, LLCANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA QuaANDACurrent
55700-575RosuvastatinRosuvastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDIRECT RXANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDirect_RxANDACurrent
61919-701ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMDirect_RxANDACurrent
68071-2326RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2848RosuvastatinRosuvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7673RosuvastatinRosuvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-0986RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1219RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1384RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70518-1601RosuvastatinRosuvastatinREMEDYREPACK INC.ANDACurrent
70934-440RosuvastatinRosuvastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-044RosuvastatinRosuvastatinProficient Rx LPANDACurrent
71205-044RosuvastatinRosuvastatinProficient Rx LPANDACurrent
71335-1446RosuvastatinRosuvastatinBryant Ranch PrepackANDACurrent
71335-1446RosuvastatinRosuvastatinBryant Ranch PrepackANDACurrent