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 |
|---|
| 2019/03/04 |
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:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:4.6MG/24HR 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 |
|---|
| 022083 |
001 |
NDA |
EXELON |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
Yes |
No |
AB |
2007/07/06
|
SANDOZ |
| 204403 |
001 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
No |
No |
AB |
2015/09/03
|
ALVOGEN |
| 205622 |
001 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
No |
No |
AB |
2018/06/20
|
MYLAN TECHNOLOGIES |
| 207308 |
001 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
No |
No |
AB |
2019/01/08
|
AMNEAL PHARMS |
| 206318 |
001 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
No |
No |
AB |
2019/03/04
|
ZYDUS PHARMS |
| 209063 |
001 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
4.6MG/24HR |
Prescription |
No |
No |
AB |
2019/11/26
|
BRECKENRIDGE |
活性成分:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:9.5MG/24HR 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 |
|---|
| 022083 |
002 |
NDA |
EXELON |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
Yes |
Yes |
AB |
2007/07/06
|
SANDOZ |
| 204403 |
002 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
No |
No |
AB |
2015/09/03
|
ALVOGEN |
| 205622 |
002 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
No |
No |
AB |
2018/06/20
|
MYLAN TECHNOLOGIES |
| 207308 |
002 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
No |
No |
AB |
2019/01/08
|
AMNEAL PHARMS |
| 206318 |
002 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
No |
No |
AB |
2019/03/04
|
ZYDUS PHARMS |
| 209063 |
002 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
9.5MG/24HR |
Prescription |
No |
No |
AB |
2019/11/26
|
BRECKENRIDGE |
活性成分:RIVASTIGMINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:13.3MG/24HR 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 |
|---|
| 022083 |
005 |
NDA |
EXELON |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
Yes |
No |
AB |
2012/08/31
|
SANDOZ |
| 204403 |
003 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
No |
No |
AB |
2015/08/31
|
ALVOGEN |
| 205622 |
003 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
No |
No |
AB |
2018/06/20
|
MYLAN TECHNOLOGIES |
| 207308 |
003 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
No |
No |
AB |
2019/01/08
|
AMNEAL PHARMS |
| 206318 |
003 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
No |
No |
AB |
2019/03/04
|
ZYDUS PHARMS |
| 209063 |
003 |
ANDA |
RIVASTIGMINE |
RIVASTIGMINE |
FILM, EXTENDED RELEASE;TRANSDERMAL |
13.3MG/24HR |
Prescription |
No |
No |
AB |
2019/11/26
|
BRECKENRIDGE |