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 |
2019/11/26 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/02 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/04/16 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/07/25 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
2012/04/30 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
2011/07/11 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
2011/06/10 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2010/12/29 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
2009/11/06 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2009/05/01 |
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:RISPERIDONE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:0.5MG 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 |
077328 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/02/24
|
DR REDDYS LABS LTD |
077494 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/04/30
|
ENDO OPERATIONS |
078516 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/05/01
|
ZYDUS PHARMS USA |
078116 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/12/22
|
SANDOZ |
077542 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2010/08/06
|
SUN PHARM INDS LTD |
090839 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2011/11/04
|
JUBILANT GENERICS |
078464 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2013/04/08
|
SUN PHARM INDS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:2MG 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 |
077328 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/02/24
|
DR REDDYS LABS LTD |
077494 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/04/30
|
ENDO OPERATIONS |
078516 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/05/01
|
ZYDUS PHARMS USA |
078116 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/12/22
|
SANDOZ |
077542 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2010/08/06
|
SUN PHARM INDS LTD |
090839 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2011/11/04
|
JUBILANT GENERICS |
078464 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2013/04/08
|
SUN PHARM INDS LTD |