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 |
|---|
| 2022/09/28 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/20 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/20 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/20 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/20 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/11/28 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/10/29 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/07/27 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/02/21 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2010/08/06 |
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:1MG 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 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2009/10/05
|
DR REDDYS LABS LTD |
| 077494 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2009/10/26
|
ENDO OPERATIONS |
| 078116 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2009/12/22
|
SANDOZ |
| 077542 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2010/08/06
|
SUN PHARM INDS LTD |
| 090839 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
Yes |
AB |
2011/11/04
|
JUBILANT GENERICS |
| 078464 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
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 |