药品注册申请号:211166
申请类型:ANDA (仿制药申请)
申请人:MACLEODS PHARMS LTD
申请人全名:MACLEODS PHARMACEUTICALS 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 SILODOSIN SILODOSIN CAPSULE;ORAL 4MG No No AB 2018/12/03 2018/12/03 Prescription
002 SILODOSIN SILODOSIN CAPSULE;ORAL 8MG No No AB 2018/12/03 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
2021/07/16 SUPPL-8(补充) Approval Labeling STANDARD
2018/12/03 ORIG-1(原始申请) Approval STANDARD
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:SILODOSIN 剂型/给药途径:CAPSULE;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
022206 001 NDA RAPAFLO SILODOSIN CAPSULE;ORAL 4MG Prescription Yes Yes AB 2008/10/08 ALLERGAN
204726 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2017/03/31 CHARTWELL RX
206541 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/03 LUPIN LTD
209745 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/03 AMNEAL PHARMS CO
210687 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/03 MSN
211060 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/03 AJANTA PHARMA LTD
211166 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/03 MACLEODS PHARMS LTD
210626 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2018/12/10 AUROBINDO PHARMA LTD
204793 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2020/02/14 HETERO LABS LTD V
213230 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2022/01/03 CREEKWOOD PHARMS
209029 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Prescription No No AB 2022/01/04 PRINSTON INC
204816 001 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 4MG Discontinued No No AB 2022/12/08 ZYDUS PHARMS
活性成分:SILODOSIN 剂型/给药途径:CAPSULE;ORAL 规格:8MG 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
022206 002 NDA RAPAFLO SILODOSIN CAPSULE;ORAL 8MG Prescription Yes No AB 2008/10/08 ALLERGAN
204726 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2017/03/31 CHARTWELL RX
206541 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/03 LUPIN LTD
209745 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/03 AMNEAL PHARMS CO
210687 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/03 MSN
211060 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/03 AJANTA PHARMA LTD
211166 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/03 MACLEODS PHARMS LTD
210626 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2018/12/10 AUROBINDO PHARMA LTD
204793 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2020/02/14 HETERO LABS LTD V
213230 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2022/01/03 CREEKWOOD PHARMS
209029 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Prescription No No AB 2022/01/04 PRINSTON INC
204816 002 ANDA SILODOSIN SILODOSIN CAPSULE;ORAL 8MG Discontinued No No AB 2022/12/08 ZYDUS PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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