FDA.reportPublic FDA data

Application 212059

Type
ANDA
Sponsor
ZHEJIANG YONGTAI

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
43547-591Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-591Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-592Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-592Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-593Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-593Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-594Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
43547-594Rosuvastatin Calciumrosuvastatin calciumSolco Healthcare LLCANDACurrent
69434-005Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-005Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-006Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-006Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-007Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-007Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-008Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent
69434-008Rosuvastatin Calciumrosuvastatin calciumZhejiang Yongtai Pharmaceutical Co., Ltd.ANDACurrent