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 |
|---|
| 2020/05/20 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/05/20 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/06/02 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/05/17 |
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:CLOPIDOGREL BISULFATE 剂型/给药途径:TABLET;ORAL 规格:EQ 75MG 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 |
|---|
| 020839 |
001 |
NDA |
PLAVIX |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
Yes |
No |
AB |
1997/11/17
|
SANOFI AVENTIS US |
| 076273 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2008/01/14
|
DR REDDYS |
| 076274 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
APOTEX INC |
| 076999 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
TEVA |
| 078004 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACME LABS |
| 090494 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Discontinued |
No |
No |
AB |
2012/05/17
|
SUN PHARM |
| 090540 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
AUROBINDO PHARMA LTD |
| 090844 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
TORRENT PHARMS LTD |
| 202925 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Discontinued |
No |
No |
AB |
2013/03/27
|
ACCORD HLTHCARE |
| 202928 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2014/02/10
|
MACLEODS PHARMS LTD |
| 203751 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2014/04/11
|
AMNEAL PHARMS |
| 204165 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2014/09/15
|
SCIEGEN PHARMS INC |
| 204359 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2017/02/02
|
RISING |
| 206376 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2018/05/07
|
PRINSTON INC |
| 213351 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2020/07/17
|
POLYGEN PHARMS |
| 205345 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2023/08/04
|
HETERO LABS LTD V |
| 203632 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2023/12/08
|
ALKEM LABS LTD |
| 091023 |
002 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2024/08/05
|
DR REDDYS LABS LTD |
| 215388 |
001 |
ANDA |
CLOPIDOGREL BISULFATE |
CLOPIDOGREL BISULFATE |
TABLET;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2024/09/20
|
MSN |
