药品注册申请号：077953
申请类型：ANDA (仿制药申请)
申请人：APOTEX INC
申请人全名：APOTEX INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 RISPERIDONE RISPERIDONE TABLET;ORAL 0.25MG No No AB 2008/09/15 2008/09/15 Prescription
002 RISPERIDONE RISPERIDONE TABLET;ORAL 0.5MG No No AB 2008/09/15 Prescription
003 RISPERIDONE RISPERIDONE TABLET;ORAL 1MG No No AB 2008/09/15 Prescription
004 RISPERIDONE RISPERIDONE TABLET;ORAL 2MG No No AB 2008/09/15 Prescription
005 RISPERIDONE RISPERIDONE TABLET;ORAL 3MG No No AB 2008/09/15 Prescription
006 RISPERIDONE RISPERIDONE TABLET;ORAL 4MG No No AB 2008/09/15 Prescription
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
2020/08/28 SUPPL-14（补充） Approval Labeling STANDARD
2020/08/28 SUPPL-13（补充） Approval Labeling STANDARD
2020/08/28 SUPPL-12（补充） Approval Labeling STANDARD
2020/08/28 SUPPL-11（补充） Approval Labeling STANDARD
2020/08/28 SUPPL-10（补充） Approval Labeling STANDARD
2014/09/23 SUPPL-9（补充） Approval Labeling STANDARD
2013/07/18 SUPPL-6（补充） Approval Labeling
2012/01/05 SUPPL-7（补充） Approval Labeling
2011/05/27 SUPPL-4（补充） Approval Labeling
2010/04/27 SUPPL-3（补充） Approval Labeling
2008/09/15 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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 ESJAY PHARMA
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RLDRSTE 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 ESJAY PHARMA
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RLDRSTE 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 ESJAY PHARMA
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RLDRSTE 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 ESJAY PHARMA
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RLDRSTE 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 ESJAY PHARMA
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RLDRSTE 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 ESJAY PHARMA
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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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