药品注册申请号:078202
申请类型:ANDA (仿制药申请)
申请人:NEPHRON
申请人全名:NEPHRON PHARMACEUTICALS CORP
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 BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML No No AN 2009/03/30 2009/03/30 Prescription
002 BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML No No AN 2009/03/30 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2015/11/30 SUPPL 5 Approval Labeling STANDARD
2009/03/30 ORIG 1 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:BUDESONIDE 剂型/给药途径:SUSPENSION;INHALATION 规格:0.25MG/2ML 治疗等效代码:AN
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
020929 001 NDA PULMICORT RESPULES BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription Yes No AN 2000/08/08 ASTRAZENECA PHARMS
077519 001 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription No No AN 2008/11/18 TEVA PHARMS
078202 001 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription No No AN 2009/03/30 NEPHRON
078404 001 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription No No AN 2012/07/31 IMPAX LABS INC
201966 003 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription No No AN 2013/09/27 SANDOZ INC
205710 001 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.25MG/2ML Prescription No No AN 2017/11/16 CIPLA
活性成分:BUDESONIDE 剂型/给药途径:SUSPENSION;INHALATION 规格:0.5MG/2ML 治疗等效代码:AN
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
020929 002 NDA PULMICORT RESPULES BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription Yes No AN 2000/08/08 ASTRAZENECA PHARMS
077519 002 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2008/11/18 TEVA PHARMS
078202 002 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2009/03/30 NEPHRON
078404 002 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2012/07/31 IMPAX LABS INC
201966 002 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2013/09/27 SANDOZ INC
205710 002 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2017/11/16 CIPLA
210897 001 ANDA BUDESONIDE BUDESONIDE SUSPENSION;INHALATION 0.5MG/2ML Prescription No No AN 2018/11/09 LUPIN ATLANTIS
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