药品注册申请号:202386
申请类型:ANDA (仿制药申请)
申请人:CHARTWELL MOLECULAR
申请人全名:CHARTWELL MOLECULAR HOLDINGS LLC
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 SOLUTION;ORAL 1MG/ML No No AA 2015/01/12 2015/01/12 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
2015/01/12 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
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
与本品治疗等效的药品
活性成分:RISPERIDONE 剂型/给药途径:SOLUTION;ORAL 规格:1MG/ML 治疗等效代码:AA
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
020588 001 NDA RISPERDAL RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription Yes Yes AA 1996/06/10 JANSSEN PHARMS
076904 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Discontinued No No AA 2009/07/29 HIKMA
077719 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Discontinued No No AA 2009/07/29 PHARM ASSOC
078452 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2009/09/04 AUROBINDO PHARMA LTD
079158 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2010/12/03 LANNETT CO INC
090347 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2011/02/07 TARO
091384 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2011/05/25 AMNEAL PHARMS
079059 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2012/12/12 TRIS PHARMA INC
202386 001 ANDA RISPERIDONE RISPERIDONE SOLUTION;ORAL 1MG/ML Prescription No No AA 2015/01/12 CHARTWELL MOLECULAR
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database