药品注册申请号:086513
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS INC
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 AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG No No AB 1979/08/03 Approved Prior to Jan 1, 1982 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
2023/04/20 SUPPL-86(补充) Approval Labeling STANDARD
2023/04/20 SUPPL-82(补充) Approval Labeling STANDARD
2023/04/20 SUPPL-80(补充) Approval Labeling STANDARD
2023/02/17 SUPPL-84(补充) Approval Manufacturing (CMC) UNKNOWN
2019/11/06 SUPPL-76(补充) Approval Labeling STANDARD
2016/06/14 SUPPL-75(补充) Approval Manufacturing (CMC) UNKNOWN
2016/01/05 SUPPL-73(补充) Approval Labeling STANDARD
2013/02/05 SUPPL-68(补充) Approval Labeling STANDARD
2002/06/03 SUPPL-53(补充) Approval Manufacturing (CMC)
2001/09/05 SUPPL-52(补充) Approval Manufacturing (CMC)
2000/04/21 SUPPL-50(补充) Approval Manufacturing (CMC)
2000/03/27 SUPPL-51(补充) Approval Labeling
1999/12/01 SUPPL-49(补充) Approval Labeling
1998/08/26 SUPPL-48(补充) Approval Labeling
1998/02/25 SUPPL-46(补充) Approval Manufacturing (CMC)
1998/02/05 SUPPL-47(补充) Approval Manufacturing (CMC)
1993/12/17 SUPPL-45(补充) Approval Manufacturing (CMC)
1993/06/09 SUPPL-43(补充) Approval Labeling
1991/05/30 SUPPL-42(补充) Approval Labeling
1990/04/04 SUPPL-41(补充) Approval Labeling
1990/01/31 SUPPL-38(补充) Approval Manufacturing (CMC)
1984/09/18 SUPPL-33(补充) Approval Manufacturing (CMC)
1982/03/18 SUPPL-30(补充) Approval Manufacturing (CMC)
1979/08/03 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
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:HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:25MG;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
086513 001 ANDA SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
012616 004 NDA ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG Prescription Yes No AB 1982/12/30 PFIZER
089534 001 ANDA SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG Prescription No No AB 1987/07/02 SUN PHARM INDUSTRIES
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