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 |
2024/03/05 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/10/25 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/11/17 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/11/17 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/26 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/26 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/11/29 |
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;ORAL 规格:0.25MG 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 |
020272 |
008 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
Yes |
No |
AB |
1999/05/10
|
JANSSEN PHARMS |
077953 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
001 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET;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 |
020272 |
007 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
Yes |
No |
AB |
1999/01/27
|
JANSSEN PHARMS |
077953 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
002 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET;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 |
020272 |
001 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
Yes |
Yes |
AB |
1993/12/29
|
JANSSEN PHARMS |
077953 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
003 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET;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 |
020272 |
002 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
Yes |
No |
AB |
1993/12/29
|
JANSSEN PHARMS |
077953 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
004 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET;ORAL 规格:3MG 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 |
020272 |
003 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
Yes |
No |
AB |
1993/12/29
|
JANSSEN PHARMS |
077953 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
005 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
3MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |
活性成分:RISPERIDONE 剂型/给药途径:TABLET;ORAL 规格:4MG 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 |
020272 |
004 |
NDA |
RISPERDAL |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
Yes |
No |
AB |
1993/12/29
|
JANSSEN PHARMS |
077953 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/09/15
|
APOTEX INC |
078269 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/10/08
|
RISING |
078871 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/10/09
|
ALLIED |
078040 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/10/16
|
ZYDUS PHARMS USA INC |
076879 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/10/24
|
DR REDDYS LABS LTD |
079088 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/10/30
|
TORRENT PHARMS |
078707 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2008/12/29
|
RENATA |
078071 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2009/06/17
|
AMNEAL |
078528 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2009/10/16
|
SANDOZ |
077543 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2011/05/18
|
CHARTWELL MOLECULAR |
201003 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2011/08/24
|
AJANTA PHARMA LTD |
077493 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2011/11/29
|
PRINSTON INC |
205104 |
006 |
ANDA |
RISPERIDONE |
RISPERIDONE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2024/06/26
|
IPCA LABS LTD |