药品注册申请号：091426
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS
申请人全名：AMNEAL PHARMACEUTICALS OF NEW YORK 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 SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG No No AB 2010/07/02 2010/07/02 Prescription
002 SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG No No AB 2010/07/02 Prescription
003 SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG No No AB 2010/07/02 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
2023/06/28 SUPPL-26（补充） Approval Labeling STANDARD
2021/02/22 SUPPL-17（补充） Approval Labeling STANDARD
2019/08/05 SUPPL-9（补充） Approval Labeling STANDARD
2015/12/02 SUPPL-7（补充） Approval Labeling STANDARD
2015/12/02 SUPPL-6（补充） Approval Labeling STANDARD
2015/12/02 SUPPL-5（补充） Approval Manufacturing (CMC) UNKNOWN
2015/12/02 SUPPL-4（补充） Approval Labeling STANDARD
2015/12/02 SUPPL-3（补充） Approval Labeling STANDARD
2011/11/28 SUPPL-2（补充） Approval Labeling
2010/07/02 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:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
012151 009 NDA ALDACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription Yes No AB 1983/12/30 PFIZER
089424 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 1986/07/23 SUN PHARM INDUSTRIES
040424 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2001/08/20 MYLAN
040750 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2006/08/29 OXFORD PHARMS
091426 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2010/07/02 AMNEAL PHARMS
202187 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2014/03/06 AUROBINDO PHARMA
203253 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2014/04/23 JUBILANT GENERICS
203512 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2016/09/19 ACCORD HLTHCARE
205936 001 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 25MG Prescription No No AB 2018/07/18 ZYDUS PHARMS
活性成分:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
012151 008 NDA ALDACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription Yes No AB 1982/12/30 PFIZER
089424 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 1999/08/11 SUN PHARM INDUSTRIES
040424 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2001/08/20 MYLAN
040750 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2006/08/29 OXFORD PHARMS
091426 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2010/07/02 AMNEAL PHARMS
202187 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2014/03/06 AUROBINDO PHARMA
203253 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2014/04/23 JUBILANT GENERICS
203512 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2016/09/19 ACCORD HLTHCARE
205936 002 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 50MG Prescription No No AB 2018/07/18 ZYDUS PHARMS
活性成分:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
012151 010 NDA ALDACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription Yes Yes AB 1983/12/30 PFIZER
089424 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 1999/08/11 SUN PHARM INDUSTRIES
040424 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2001/08/20 MYLAN
040750 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2006/08/29 OXFORD PHARMS
091426 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2010/07/02 AMNEAL PHARMS
202187 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2014/03/06 AUROBINDO PHARMA
203253 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2014/04/23 JUBILANT GENERICS
203512 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2016/09/19 ACCORD HLTHCARE
205936 003 ANDA SPIRONOLACTONE SPIRONOLACTONE TABLET;ORAL 100MG Prescription No No AB 2018/07/18 ZYDUS PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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