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 |
|---|
| 2023/10/31 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/06/02 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/14 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/09/14 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/11/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/04/24 |
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:RABEPRAZOLE SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:20MG 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 |
|---|
| 020973 |
002 |
NDA |
ACIPHEX |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
Yes |
Yes |
AB |
1999/08/19
|
WAYLIS THERAP |
| 076822 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2013/11/08
|
TEVA PHARMS USA |
| 076824 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2013/11/08
|
DR REDDYS |
| 078964 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2013/11/08
|
CHARTWELL RX |
| 090678 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2013/11/08
|
LANNETT CO INC |
| 202376 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2013/11/08
|
TORRENT |
| 204179 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/07/31
|
AMNEAL PHARMS |
| 204237 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/11/18
|
RUBICON |
| 205761 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2017/02/17
|
AUROBINDO PHARMA |
| 208644 |
001 |
ANDA |
RABEPRAZOLE SODIUM |
RABEPRAZOLE SODIUM |
TABLET, DELAYED RELEASE;ORAL |
20MG |
Prescription |
No |
No |
AB |
2018/04/24
|
ALKEM LABS LTD |