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 |
|---|
| 2023/04/25 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/05/04 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/05/04 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/05/04 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/05/04 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/22 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/22 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/22 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/22 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/10/06 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/11/04 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/12/29 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/11/27 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/07/17 |
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 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 |
