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Application 206513

Type
ANDA
Sponsor
ZYDUS PHARMS

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
68382-627RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-627RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-628RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-628RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-629RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-629RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-630RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-630RosuvastatinRosuvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1481RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1481RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1482RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1482RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1483RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1483RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1483RosuvastatinRosuvastatinZydus Lifesciences LimitedANDACurrent
70771-1484RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent
70771-1484RosuvastatinRosuvastatinCadila Healthcare LimitedANDACurrent