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 |
|---|
| 2024/08/13 |
SUPPL-20（补充） |
Approval |
REMS |
|
|
|
| 2021/08/11 |
SUPPL-17（补充） |
Approval |
REMS |
|
|
|
| 2021/04/21 |
SUPPL-15（补充） |
Approval |
REMS |
|
|
|
| 2021/01/15 |
SUPPL-14（补充） |
Approval |
REMS |
|
|
|
| 2015/11/13 |
SUPPL-3（补充） |
Approval |
REMS |
|
|
|
| 2014/01/08 |
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:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 360MG 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 |
|---|
| 050791 |
002 |
NDA |
MYFORTIC |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
Yes |
Yes |
AB |
2004/02/27
|
NOVARTIS |
| 091248 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2014/01/08
|
RK PHARMA |
| 091558 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2014/08/19
|
APOTEX INC |
| 202555 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2017/08/23
|
ACCORD HLTHCARE |
| 211173 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2019/12/13
|
CONCORD BIOTECH LTD |
| 214376 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2021/02/10
|
AMTA |
| 208315 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2021/09/23
|
ALKEM LABS LTD |
| 214289 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2021/11/03
|
TWI PHARMS |
| 214630 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2021/11/29
|
BIOCON PHARMA |
| 217031 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2023/11/29
|
BIOCON PHARMA |
| 218603 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2024/02/27
|
AUROBINDO PHARMA LTD |
| 216637 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 360MG BASE |
Prescription |
No |
No |
AB |
2024/05/29
|
WANBANG BIOPHARMS |
活性成分:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 180MG 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 |
|---|
| 050791 |
001 |
NDA |
MYFORTIC |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
Yes |
No |
AB |
2004/02/27
|
NOVARTIS |
| 091558 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2012/08/21
|
APOTEX INC |
| 091248 |
002 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2014/01/08
|
RK PHARMA |
| 202555 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2017/08/23
|
ACCORD HLTHCARE |
| 211173 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2019/12/13
|
CONCORD BIOTECH LTD |
| 214376 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2021/02/10
|
AMTA |
| 208315 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2021/09/23
|
ALKEM LABS LTD |
| 214289 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2021/11/03
|
TWI PHARMS |
| 214630 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2021/11/29
|
BIOCON PHARMA |
| 217031 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2023/11/29
|
BIOCON PHARMA |
| 218603 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2024/02/27
|
AUROBINDO PHARMA LTD |
| 216637 |
001 |
ANDA |
MYCOPHENOLIC SODIUM |
MYCOPHENOLIC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
EQ 180MG BASE |
Prescription |
No |
No |
AB |
2024/05/29
|
WANBANG BIOPHARMS |
