药品注册申请号：079171
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE No No AB 2016/07/19 2016/07/19 Discontinued
002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE No No AB 2016/07/19 Discontinued
003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE No No AB 2016/07/19 Discontinued
004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE No No AB 2016/07/19 Discontinued
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2016/07/19 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/12/19 SUPPL-15（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2023/11/22 SUPPL-14（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2023/07/13 SUPPL-13（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2023/07/13 SUPPL-7（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2023/07/13 SUPPL-6（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2020/03/09 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2020/03/09 SUPPL-2（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
>>>活性成分:ROSUVASTATIN CALCIUM; 剂型/给药途径:TABLET;ORAL; 规格:EQ 5MG BASE; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021366 002 NDA CRESTOR ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2003/08/12 ASTRAZENECA
079167 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/04/29 WATSON LABS INC
079168 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/07/19 CHARTWELL RX
079169 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2016/07/19 SUN PHARM
079170 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/07/19 AUROBINDO PHARMA LTD
079171 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2016/07/19 SANDOZ
079172 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/07/19 GLENMARK SPECLT
201619 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 TORRENT
206434 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 ACCORD HLTHCARE
207062 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 RENATA
207408 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 CHANGZHOU PHARM
207616 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 HETERO LABS LTD V
207752 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/10/31 BIOCON PHARMA
207453 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2016/11/23 CADILA PHARMS LTD
206465 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/03/21 ALKEM LABS LTD
205587 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/07/31 LUPIN
208898 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/11/22 MSN
206513 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/03/01 ZHEJIANG JINGXIN
207626 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/04/09 UMEDICA
206381 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/04/24 SCIEGEN PHARMS INC
207375 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/05/07 SHANDONG
212059 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2019/11/04 ZHEJIANG YONGTAI
207296 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2024/11/06 MACLEODS PHARMS LTD
206603 001 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2025/05/16 MANKIND PHARMA
>>>活性成分:ROSUVASTATIN CALCIUM; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG BASE; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021366 003 NDA CRESTOR ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 2003/08/12 ASTRAZENECA
079167 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/04/29 WATSON LABS INC
079168 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/07/19 CHARTWELL RX
079169 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2016/07/19 SUN PHARM
079170 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/07/19 AUROBINDO PHARMA LTD
079171 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2016/07/19 SANDOZ
079172 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/07/19 GLENMARK SPECLT
201619 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 TORRENT
206434 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 ACCORD HLTHCARE
207062 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 RENATA
207408 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 CHANGZHOU PHARM
207616 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 HETERO LABS LTD V
207752 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/10/31 BIOCON PHARMA
207453 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2016/11/23 CADILA PHARMS LTD
206465 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/03/21 ALKEM LABS LTD
205587 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/07/31 LUPIN
208898 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/11/22 MSN
206513 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/03/01 ZHEJIANG JINGXIN
207626 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/04/09 UMEDICA
206381 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/04/24 SCIEGEN PHARMS INC
207375 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/05/07 SHANDONG
212059 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2019/11/04 ZHEJIANG YONGTAI
207296 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2024/11/06 MACLEODS PHARMS LTD
206603 002 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2025/05/16 MANKIND PHARMA
>>>活性成分:ROSUVASTATIN CALCIUM; 剂型/给药途径:TABLET;ORAL; 规格:EQ 20MG BASE; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021366 004 NDA CRESTOR ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription Yes No AB 2003/08/12 ASTRAZENECA
079167 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/04/29 WATSON LABS INC
079168 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/07/19 CHARTWELL RX
079169 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2016/07/19 SUN PHARM
079170 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/07/19 AUROBINDO PHARMA LTD
079171 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2016/07/19 SANDOZ
079172 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/07/19 GLENMARK SPECLT
201619 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 TORRENT
206434 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 ACCORD HLTHCARE
207062 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 RENATA
207408 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 CHANGZHOU PHARM
207616 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 HETERO LABS LTD V
207752 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/10/31 BIOCON PHARMA
207453 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/11/23 CADILA PHARMS LTD
206465 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/03/21 ALKEM LABS LTD
205587 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/07/31 LUPIN
208898 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/11/22 MSN
206513 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/03/01 ZHEJIANG JINGXIN
207626 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/04/09 UMEDICA
206381 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/04/24 SCIEGEN PHARMS INC
207375 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/05/07 SHANDONG
212059 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Prescription No No AB 2019/11/04 ZHEJIANG YONGTAI
207296 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2024/11/06 MACLEODS PHARMS LTD
206603 003 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2025/05/16 MANKIND PHARMA
>>>活性成分:ROSUVASTATIN CALCIUM; 剂型/给药途径:TABLET;ORAL; 规格:EQ 40MG BASE; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021366 005 NDA CRESTOR ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription Yes Yes AB 2003/08/12 ASTRAZENECA
079167 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/04/29 WATSON LABS INC
079168 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/07/19 CHARTWELL RX
079169 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2016/07/19 SUN PHARM
079170 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/07/19 AUROBINDO PHARMA LTD
079171 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2016/07/19 SANDOZ
079172 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/07/19 GLENMARK SPECLT
201619 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 TORRENT
206434 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 ACCORD HLTHCARE
207062 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 RENATA
207408 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 CHANGZHOU PHARM
207616 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 HETERO LABS LTD V
207752 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/10/31 BIOCON PHARMA
207453 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2016/11/23 CADILA PHARMS LTD
206465 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2017/03/21 ALKEM LABS LTD
205587 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2017/07/31 LUPIN
208898 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2017/11/22 MSN
206513 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/03/01 ZHEJIANG JINGXIN
207626 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/04/09 UMEDICA
206381 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/04/24 SCIEGEN PHARMS INC
207375 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/05/07 SHANDONG
212059 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2019/11/04 ZHEJIANG YONGTAI
207296 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2024/11/06 MACLEODS PHARMS LTD
206603 004 ANDA ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2025/05/16 MANKIND PHARMA
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