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 |
2024/12/04 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/03/15 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/08 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/10/06 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/23 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/01/27 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/20 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2012/01/17 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2011/11/30 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:ATORVASTATIN 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 |
020702 |
001 |
NDA |
LIPITOR |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
Yes |
No |
AB |
1996/12/17
|
UPJOHN |
076477 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
SUN PHARM INDS LTD |
077575 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
CHARTWELL RX |
090548 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
APOTEX INC |
091226 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
MYLAN PHARMS INC |
091650 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/07/17
|
DR REDDYS LABS LTD |
091624 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2013/04/05
|
LANNETT CO INC |
205519 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2016/05/19
|
SCIEGEN PHARMS INC |
204846 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2017/01/09
|
INVAGEN PHARMS |
205300 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2017/03/27
|
TEVA PHARMS USA |
207687 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2018/03/30
|
ACCORD HLTHCARE |
209912 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2018/06/18
|
GRAVITI PHARMS |
206536 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2018/11/20
|
ZYDUS PHARMS |
209288 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2018/12/21
|
ALKEM LABS LTD |
211933 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/02/08
|
MSN |
205945 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/11/07
|
MICRO LABS LTD INDIA |
214659 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2021/07/14
|
DR REDDYS |
214969 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2021/09/02
|
AGNITIO |
216848 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2022/11/03
|
LEPU PHARM |
216436 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2022/11/23
|
BIOCON PHARMA |
214344 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2023/09/12
|
HETERO LABS LTD V |
212103 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2023/10/16
|
CADILA PHARMS LTD |
217634 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2023/12/21
|
STRIDES PHARMA |
217081 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/01/05
|
MANKIND PHARMA |
214513 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/01/22
|
LAURUS |
211886 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/01/25
|
SHANDONG XINHUA |
217118 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/02/13
|
AUROBINDO PHARMA LTD |
208480 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/06/03
|
MACLEODS PHARMS LTD |
活性成分:ATORVASTATIN 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 |
020702 |
002 |
NDA |
LIPITOR |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
Yes |
No |
AB |
1996/12/17
|
UPJOHN |
076477 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
SUN PHARM INDS LTD |
077575 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
CHARTWELL RX |
090548 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
APOTEX INC |
091226 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
MYLAN PHARMS INC |
091650 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2012/07/17
|
DR REDDYS LABS LTD |
091624 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2013/04/05
|
LANNETT CO INC |
205519 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2016/05/19
|
SCIEGEN PHARMS INC |
204846 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2017/01/09
|
INVAGEN PHARMS |
205300 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2017/03/27
|
TEVA PHARMS USA |
207687 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2018/03/30
|
ACCORD HLTHCARE |
209912 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2018/06/18
|
GRAVITI PHARMS |
206536 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2018/11/20
|
ZYDUS PHARMS |
209288 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2018/12/21
|
ALKEM LABS LTD |
211933 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2019/02/08
|
MSN |
205945 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2019/11/07
|
MICRO LABS LTD INDIA |
214659 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2021/07/14
|
DR REDDYS |
214969 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2021/09/02
|
AGNITIO |
216848 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2022/11/03
|
LEPU PHARM |
216436 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2022/11/23
|
BIOCON PHARMA |
214344 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2023/09/12
|
HETERO LABS LTD V |
212103 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2023/10/16
|
CADILA PHARMS LTD |
217634 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2023/12/21
|
STRIDES PHARMA |
217081 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/01/05
|
MANKIND PHARMA |
214513 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/01/22
|
LAURUS |
211886 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/01/25
|
SHANDONG XINHUA |
217118 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/02/13
|
AUROBINDO PHARMA LTD |
208480 |
002 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/06/03
|
MACLEODS PHARMS LTD |
活性成分:ATORVASTATIN 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 |
020702 |
003 |
NDA |
LIPITOR |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
Yes |
No |
AB |
1996/12/17
|
UPJOHN |
076477 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
SUN PHARM INDS LTD |
077575 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
CHARTWELL RX |
090548 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
APOTEX INC |
091226 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
MYLAN PHARMS INC |
091650 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/07/17
|
DR REDDYS LABS LTD |
091624 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2013/04/05
|
LANNETT CO INC |
205519 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2016/05/19
|
SCIEGEN PHARMS INC |
204846 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Discontinued |
No |
No |
AB |
2017/01/09
|
INVAGEN PHARMS |
205300 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2017/03/27
|
TEVA PHARMS USA |
207687 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2018/03/30
|
ACCORD HLTHCARE |
209912 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2018/06/18
|
GRAVITI PHARMS |
206536 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2018/11/20
|
ZYDUS PHARMS |
209288 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2018/12/21
|
ALKEM LABS LTD |
211933 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2019/02/08
|
MSN |
205945 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2019/11/07
|
MICRO LABS LTD INDIA |
214659 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2021/07/14
|
DR REDDYS |
214969 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2021/09/02
|
AGNITIO |
216848 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Discontinued |
No |
No |
AB |
2022/11/03
|
LEPU PHARM |
216436 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2022/11/23
|
BIOCON PHARMA |
214344 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2023/09/12
|
HETERO LABS LTD V |
212103 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Discontinued |
No |
No |
AB |
2023/10/16
|
CADILA PHARMS LTD |
217634 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Discontinued |
No |
No |
AB |
2023/12/21
|
STRIDES PHARMA |
217081 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2024/01/05
|
MANKIND PHARMA |
214513 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2024/01/22
|
LAURUS |
211886 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2024/01/25
|
SHANDONG XINHUA |
217118 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2024/02/13
|
AUROBINDO PHARMA LTD |
208480 |
003 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2024/06/03
|
MACLEODS PHARMS LTD |
活性成分:ATORVASTATIN CALCIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 80MG 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 |
020702 |
004 |
NDA |
LIPITOR |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
Yes |
Yes |
AB |
2000/04/07
|
UPJOHN |
076477 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
SUN PHARM INDS LTD |
077575 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
CHARTWELL RX |
090548 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
APOTEX INC |
091226 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2012/05/29
|
MYLAN PHARMS INC |
202357 |
001 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2012/07/17
|
DR REDDYS LABS LTD |
091624 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2013/04/05
|
LANNETT CO INC |
205519 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2016/05/19
|
SCIEGEN PHARMS INC |
204846 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Discontinued |
No |
No |
AB |
2017/01/09
|
INVAGEN PHARMS |
205300 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2017/03/27
|
TEVA PHARMS USA |
207687 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2018/03/30
|
ACCORD HLTHCARE |
209912 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2018/06/18
|
GRAVITI PHARMS |
206536 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2018/11/20
|
ZYDUS PHARMS |
209288 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2018/12/21
|
ALKEM LABS LTD |
211933 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2019/02/08
|
MSN |
205945 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2019/11/07
|
MICRO LABS LTD INDIA |
214659 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2021/07/14
|
DR REDDYS |
214969 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2021/09/02
|
AGNITIO |
216848 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Discontinued |
No |
No |
AB |
2022/11/03
|
LEPU PHARM |
216436 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2022/11/23
|
BIOCON PHARMA |
214344 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2023/09/12
|
HETERO LABS LTD V |
212103 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Discontinued |
No |
No |
AB |
2023/10/16
|
CADILA PHARMS LTD |
217634 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Discontinued |
No |
No |
AB |
2023/12/21
|
STRIDES PHARMA |
217081 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2024/01/05
|
MANKIND PHARMA |
214513 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2024/01/22
|
LAURUS |
211886 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2024/01/25
|
SHANDONG XINHUA |
217118 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2024/02/13
|
AUROBINDO PHARMA LTD |
208480 |
004 |
ANDA |
ATORVASTATIN CALCIUM |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2024/06/03
|
MACLEODS PHARMS LTD |