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
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 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 |
2020/02/21 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/22 |
ORIG-1(原始申请) |
Approval |
|
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 | RLD | RS | TE 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
|
IPR |
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 |
Prescription |
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 |
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 |
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 | RLD | RS | TE 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
|
IPR |
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 |
Prescription |
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 |
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 |
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 | RLD | RS | TE 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
|
IPR |
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 |
Prescription |
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 |
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 |
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 | RLD | RS | TE 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
|
IPR |
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 |
Prescription |
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 |
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 |