药品注册申请号:202433
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA LTD
申请人全名:AUROBINDO PHARMA LTD
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 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG No No AB 2013/04/30 2013/04/30 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
2019/09/09 SUPPL-12(补充) Approval Labeling STANDARD
2015/07/11 SUPPL-4(补充) Approval Labeling STANDARD
2015/07/11 SUPPL-3(补充) Approval Labeling STANDARD
2015/07/11 SUPPL-1(补充) Approval Labeling STANDARD
2013/04/30 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:TAMSULOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:0.4MG 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
020579 001 NDA FLOMAX TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription Yes Yes AB 1997/04/15 SANOFI
090377 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/03/02 IMPAX LABS
077630 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/04/27 TEVA PHARMS
078015 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/04/27 SANDOZ
078225 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/04/27 ZYDUS PHARMS USA INC
078801 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/04/27 SYNTHON PHARMS
078938 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/04/27 WOCKHARDT
090931 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2010/07/15 SUN PHARM INDS LTD
202433 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2013/04/30 AUROBINDO PHARMA LTD
204645 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2017/01/20 MACLEODS PHARMS LTD
207405 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2017/08/11 ALKEM LABS LTD
211885 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Prescription No No AB 2019/10/17 CHARTWELL RX
214730 001 ANDA TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG Discontinued No No AB 2022/05/04 ASCENT PHARMS INC
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