药品注册申请号:209450
申请类型:ANDA (仿制药申请)
申请人:AMNEAL
申请人全名:AMNEAL PHARMACEUTICALS 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 LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG No No AB 2021/11/30 2021/11/30 Prescription
002 LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG No No AB 2021/11/30 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
2022/05/05 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2021/11/30 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:LUBIPROSTONE 剂型/给药途径:CAPSULE;ORAL 规格:8MCG 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
021908 002 NDA AMITIZA LUBIPROSTONE CAPSULE;ORAL 8MCG Prescription Yes No AB 2008/04/29 SUCAMPO PHARMA LLC
209450 001 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG Prescription No No AB 2021/11/30 AMNEAL
209920 001 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG Prescription No No AB 2022/01/18 TEVA PHARMS USA INC
206994 001 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG Prescription No No AB 2022/02/08 DR REDDYS
201442 001 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG Discontinued No No AB 2022/06/27 ENDO OPERATIONS
214131 001 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 8MCG Prescription No No AB 2023/03/23 ZYDUS PHARMS
活性成分:LUBIPROSTONE 剂型/给药途径:CAPSULE;ORAL 规格:24MCG 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
021908 001 NDA AMITIZA LUBIPROSTONE CAPSULE;ORAL 24MCG Prescription Yes Yes AB 2006/01/31 SUCAMPO PHARMA LLC
209450 002 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG Prescription No No AB 2021/11/30 AMNEAL
209920 002 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG Prescription No No AB 2022/01/18 TEVA PHARMS USA INC
206994 002 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG Prescription No No AB 2022/02/08 DR REDDYS
201442 002 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG Discontinued No No AB 2022/06/27 ENDO OPERATIONS
214131 002 ANDA LUBIPROSTONE LUBIPROSTONE CAPSULE;ORAL 24MCG Prescription No No AB 2023/03/23 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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