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-53(补充) |
Approval |
REMS |
N/A
|
|
|
2022/08/10 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/06/06 |
SUPPL-51(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/06/06 |
SUPPL-49(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/10/22 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/10/22 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/08/11 |
SUPPL-48(补充) |
Approval |
REMS |
N/A
|
|
|
2021/04/21 |
SUPPL-47(补充) |
Approval |
REMS |
N/A
|
|
|
2021/01/15 |
SUPPL-44(补充) |
Approval |
REMS |
N/A
|
|
|
2019/12/13 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/02/27 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/08/23 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/12/18 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/13 |
SUPPL-34(补充) |
Approval |
REMS |
N/A
|
|
|
2015/07/09 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/23 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/09/27 |
SUPPL-31(补充) |
Approval |
REMS |
N/A
|
|
|
2013/09/27 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/02/14 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2012/09/25 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/06/22 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/06/08 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/08 |
SUPPL-24(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2009/06/18 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/02/27 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/12/15 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/09 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/20 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/09/21 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/10/17 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/02/28 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/05/31 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/11/14 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/12/20 |
SUPPL-7(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2000/07/28 |
SUPPL-5(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2000/07/27 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/05/15 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/04/13 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/02/11 |
SUPPL-2(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1997/06/12 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/05/03 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 |
001 |
4753935 |
2009/05/03 |
Y |
Y |
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
与本品治疗等效的药品
活性成分:MYCOPHENOLATE MOFETIL 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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 |
050722 |
001 |
NDA |
CELLCEPT |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
Yes |
Yes |
AB |
1995/05/03
|
ROCHE PALO |
065410 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2008/07/29
|
HIKMA |
065379 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2008/10/15
|
SANDOZ |
090253 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2009/05/04
|
ACCORD HLTHCARE |
065520 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2009/05/04
|
MYLAN |
065491 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2009/05/06
|
TEVA PHARMS |
090055 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2010/06/10
|
STRIDES PHARMA |
200197 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2013/06/13
|
ALKEM LABS LTD |
204077 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2017/11/13
|
ZHEJIANG HISUN PHARM |
210181 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/01/08
|
CONCORD BIOTECH LTD |
217828 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2024/01/05
|
AUROBINDO PHARMA LTD |
207022 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2024/10/22
|
HETERO LABS LTD V |
214079 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL |
MYCOPHENOLATE MOFETIL |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2024/11/07
|
WUXI |