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 |
|---|
| 2023/09/27 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/06/09 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/06/09 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/12/20 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/03/01 |
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:PANTOPRAZOLE SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;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 |
|---|
| 020987 |
001 |
NDA |
PROTONIX |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
Yes |
Yes |
AB |
2000/02/02
|
WYETH PHARMS |
| 077619 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/01/19
|
DR REDDYS LABS LTD |
| 090074 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/01/19
|
TORRENT PHARMS |
| 090970 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/01/19
|
MYLAN PHARMS INC |
| 091231 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/01/19
|
WOCKHARDT BIO AG |
| 078281 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/01/20
|
LANNETT CO INC |
| 090797 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2011/02/07
|
ACTAVIS TOTOWA |
| 090807 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/05/02
|
RUBICON |
| 202038 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2012/09/28
|
AUROBINDO PHARMA LTD |
| 202882 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2014/09/10
|
HETERO LABS LTD V |
| 202052 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2014/12/02
|
ORBION PHARMS |
| 205119 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2016/01/26
|
AMNEAL PHARMS |
| 211368 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2019/03/01
|
INGENUS PHARMS LLC |
| 215880 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2022/07/26
|
MANKIND PHARMA |
| 217282 |
002 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2023/12/11
|
GRANULES |