药品名称PROCYSBI
申请号203389产品号002
活性成分CYSTEAMINE BITARTRATE市场状态处方药
剂型或给药途径CAPSULE, DELAYED RELEASE;ORAL规格EQ 75MG BASE
治疗等效代码参比药物是
批准日期2013/04/30申请机构RAPTOR PHARMACEUTICALS INC
化学类型New formulation or new manufacturer审评分类Standard review drug
与本品相关的专利信息（来自橙皮书Orange Book）
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
91925902027/01/26U-1399PDF格式
91988822027/01/26U-1399PDF格式
80262842027/09/22U-1399PDF格式
92330772034/06/17YPDF格式
91738512034/06/17YPDF格式
历史专利信息
81294332027/01/26YPDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
NDF2016/04/30
ODE2020/04/30
NPP2018/08/14
ODE2022/08/14
历史市场独占权保护信息
无
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
203389010APLabel2015/08/17下载
203389010APLetter2015/08/18下载
203389000APLetter2013/05/01下载
203389000APLabel2013/05/01下载
203389000APReview2014/03/06下载
203389000APSummary Review2014/03/06下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
203389016AP2016/03/21Manufacturing Change or Addition
203389015AP2016/05/13Manufacturing Change or Addition
203389014AP2016/03/10Manufacturing Change or Addition
203389013AP2015/09/09Manufacturing Change or Addition
203389012AP2015/04/08Manufacturing Change or Addition
203389011AP2014/12/02Manufacturing Change or Addition
203389010AP2015/08/14Efficacy Supplement with Clinical Data to Support
203389005AP2014/04/21Manufacturing Change or Addition
203389004AP2014/01/30Manufacturing Change or Addition
203389003AP2013/10/31Manufacturing Change or Addition
203389002AP2013/10/18Manufacturing Change or Addition
203389001AP2013/10/08Manufacturing Change or Addition
203389000AP2013/04/30Approval