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 |
|---|
| 2022/01/26 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/10/31 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2011/04/29 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 2004/03/24 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2002/02/19 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2002/02/19 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/09/26 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/04 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2001/04/04 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/01/08 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/12/22 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2000/04/17 |
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:ISOSORBIDE MONONITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:60MG 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 |
|---|
| 075155 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
1998/10/30
|
CHARTWELL MOLECULAR |
| 075395 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2000/03/16
|
ZYDUS HLTHCARE |
| 075522 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2000/04/17
|
DEXCEL LTD |
| 200495 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2011/06/03
|
TORRENT PHARMS |
| 210918 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2018/11/05
|
RICONPHARMA LLC |
| 216557 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2022/11/07
|
AUROBINDO PHARMA |
| 214115 |
003 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2024/02/08
|
SHANDONG |
| 218255 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Discontinued |
No |
No |
AB |
2024/02/15
|
ZYDUS PHARMS |
活性成分:ISOSORBIDE MONONITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:30MG 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 |
|---|
| 075155 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2000/01/13
|
CHARTWELL MOLECULAR |
| 075395 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2000/03/16
|
ZYDUS HLTHCARE |
| 200270 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2011/06/03
|
TORRENT PHARMS |
| 075522 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2016/09/20
|
DEXCEL LTD |
| 210918 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2018/11/05
|
RICONPHARMA LLC |
| 216557 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2022/11/07
|
AUROBINDO PHARMA |
| 214115 |
002 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2024/02/08
|
SHANDONG |
| 218255 |
001 |
ANDA |
ISOSORBIDE MONONITRATE |
ISOSORBIDE MONONITRATE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2024/02/15
|
ZYDUS PHARMS |
