药品注册申请号：078116
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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, ORALLY DISINTEGRATING;ORAL 0.5MG No No AB 2009/12/22 2009/12/22 Prescription
002 RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 1MG No No AB 2009/12/22 Prescription
003 RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 2MG No No AB 2009/12/22 Prescription
004 RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG No No AB 2009/12/22 Prescription
005 RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG No No AB 2009/12/22 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
2022/09/01 SUPPL-16（补充） Approval Labeling STANDARD
2022/09/01 SUPPL-15（补充） Approval Labeling STANDARD
2022/09/01 SUPPL-14（补充） Approval Labeling STANDARD
2022/09/01 SUPPL-13（补充） Approval Labeling STANDARD
2022/09/01 SUPPL-12（补充） Approval Labeling STANDARD
2014/11/28 SUPPL-11（补充） Approval Labeling STANDARD
2013/04/10 SUPPL-10（补充） Approval Labeling STANDARD
2012/04/30 SUPPL-4（补充） Approval Labeling
2012/03/01 SUPPL-2（补充） Approval Labeling
2012/02/21 SUPPL-3（补充） Approval Labeling
2011/06/10 SUPPL-1（补充） Approval Labeling
2009/12/22 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, 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RLDRSTE 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RLDRSTE 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RLDRSTE 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
活性成分:RISPERIDONE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;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
077494 005 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG Prescription No No AB 2009/04/30 ENDO OPERATIONS
077328 004 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG Prescription No No AB 2009/11/30 DR REDDYS LABS LTD
078116 004 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG Prescription No No AB 2009/12/22 SANDOZ
078474 001 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG Prescription No No AB 2010/08/06 SUN PHARM INDS LTD
090839 004 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG Prescription No No AB 2011/11/04 JUBILANT GENERICS
078464 004 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 3MG 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: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
077494 006 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2009/04/30 ENDO OPERATIONS
077328 005 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2009/11/30 DR REDDYS LABS LTD
078116 005 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2009/12/22 SANDOZ
078474 002 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2010/08/06 SUN PHARM INDS LTD
090839 005 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2011/11/04 JUBILANT GENERICS
078464 005 ANDA RISPERIDONE RISPERIDONE TABLET, ORALLY DISINTEGRATING;ORAL 4MG Prescription No No AB 2013/04/08 SUN PHARM INDS 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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