药品注册申请号：076725
申请类型：ANDA (仿制药申请)
申请人：UPSHER SMITH LABS
申请人全名：UPSHER SMITH LABORATORIES 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 ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG No No AB 2004/11/03 2004/11/03 Prescription
002 ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG No Yes AB 2004/11/03 Prescription
003 ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2004/11/03 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
2019/11/13 SUPPL-17（补充） Approval Labeling STANDARD
2005/05/05 SUPPL-3（补充） Approval Labeling
2004/11/03 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
无
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
无
与本品治疗等效的药品
活性成分:MIDODRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
076577 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2003/09/10 MYLAN PHARMS INC
076449 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2004/05/27 IMPAX PHARMS
076725 001 ANDA ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2004/11/03 UPSHER SMITH LABS
077746 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2006/09/12 APOTEX
207169 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2018/10/29 ENDO OPERATIONS
207613 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2018/11/02 THINQ PHARM-CRO PVT
212543 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2019/08/19 RUBICON
212774 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2020/08/10 AUROBINDO PHARMA LTD
213055 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2020/09/01 ZYDUS LIFESCIENCES
207849 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2020/10/01 XIROMED
214734 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2021/01/21 ALEMBIC
211973 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/10/17 NOVUGEN
217271 001 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG Prescription No No AB 2023/11/01 MANKIND PHARMA
活性成分:MIDODRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
076577 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2003/09/10 MYLAN PHARMS INC
076449 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2004/05/27 IMPAX PHARMS
076725 002 ANDA ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No Yes AB 2004/11/03 UPSHER SMITH LABS
077746 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/09/12 APOTEX
207169 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/10/29 ENDO OPERATIONS
207613 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/11/02 THINQ PHARM-CRO PVT
212543 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/08/19 RUBICON
212774 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/08/10 AUROBINDO PHARMA LTD
213055 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/09/01 ZYDUS LIFESCIENCES
207849 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/10/01 XIROMED
214734 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2021/01/21 ALEMBIC
211973 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/10/17 NOVUGEN
217271 002 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2023/11/01 MANKIND PHARMA
活性成分:MIDODRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
076577 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2003/09/10 MYLAN PHARMS INC
076725 003 ANDA ORVATEN MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/11/03 UPSHER SMITH LABS
076449 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2005/12/16 IMPAX PHARMS
077746 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2006/09/12 APOTEX
207169 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/10/29 ENDO OPERATIONS
207613 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/11/02 THINQ PHARM-CRO PVT
212543 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2019/08/19 RUBICON
212774 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/08/10 AUROBINDO PHARMA LTD
213055 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/09/01 ZYDUS LIFESCIENCES
207849 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/10/01 XIROMED
214734 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/01/21 ALEMBIC
211973 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/10/17 NOVUGEN
217271 003 ANDA MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/11/01 MANKIND PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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