药品注册申请号:071251
申请类型:ANDA (仿制药申请)
申请人:APOTEX INC
申请人全名:APOTEX 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 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG No No AB 1987/12/08 1988/04/17 Prescription
002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG No No AB 1998/05/05 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
2020/12/10 SUPPL-48(补充) Approval Labeling STANDARD
2012/01/19 SUPPL-41(补充) Approval Labeling
2009/04/29 SUPPL-40(补充) Approval Labeling
2002/03/13 SUPPL-29(补充) Approval Manufacturing (CMC)
2000/06/27 SUPPL-28(补充) Approval Manufacturing (CMC)
1999/12/21 SUPPL-27(补充) Approval Manufacturing (CMC)
1999/05/20 SUPPL-26(补充) Approval Manufacturing (CMC)
1999/03/04 SUPPL-25(补充) Approval Manufacturing (CMC)
1998/12/01 SUPPL-24(补充) Approval Manufacturing (CMC)
1998/10/08 SUPPL-23(补充) Approval Manufacturing (CMC)
1998/05/05 SUPPL-22(补充) Approval Manufacturing (CMC)
1998/05/05 SUPPL-21(补充) Approval Manufacturing (CMC)
1998/05/05 SUPPL-20(补充) Approval Manufacturing (CMC)
1998/05/05 SUPPL-19(补充) Approval Labeling
1997/06/23 SUPPL-18(补充) Approval Labeling
1997/04/07 SUPPL-17(补充) Approval Manufacturing (CMC)
1995/11/02 SUPPL-16(补充) Approval Manufacturing (CMC)
1995/06/23 SUPPL-15(补充) Approval Manufacturing (CMC)
1994/12/23 SUPPL-14(补充) Approval Manufacturing (CMC)
1994/10/11 SUPPL-13(补充) Approval Manufacturing (CMC)
1993/06/09 SUPPL-12(补充) Approval Labeling
1992/10/05 SUPPL-11(补充) Approval Labeling
1992/04/03 SUPPL-10(补充) Approval Manufacturing (CMC)
1992/04/03 SUPPL-8(补充) Approval Manufacturing (CMC)
1991/12/03 SUPPL-4(补充) Approval Labeling
1989/10/26 SUPPL-6(补充) Approval Bioequivalence
1989/10/20 SUPPL-5(补充) Approval Bioequivalence
1988/06/02 SUPPL-2(补充) Approval Manufacturing (CMC)
1988/05/06 SUPPL-3(补充) Approval Manufacturing (CMC)
1988/05/06 SUPPL-1(补充) Approval Manufacturing (CMC)
1987/12/08 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; TRIAMTERENE 剂型/给药途径:TABLET;ORAL 规格:50MG;75MG 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
019129 001 NDA MAXZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription Yes Yes AB 1984/10/22 AUROBINDO PHARMA USA
071251 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription No No AB 1988/04/17 APOTEX INC
072011 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription No No AB 1988/06/17 SANDOZ
071851 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription No No AB 1988/11/30 WATSON LABS
208360 002 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription No No AB 2018/06/29 ZYDUS PHARMS
216211 002 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG Prescription No No AB 2022/02/23 RUBICON
活性成分:HYDROCHLOROTHIAZIDE; TRIAMTERENE 剂型/给药途径:TABLET;ORAL 规格:25MG;37.5MG 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
019129 003 NDA MAXZIDE-25 HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription Yes No AB 1988/05/13 AUROBINDO PHARMA USA
073281 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription No No AB 1992/04/30 SANDOZ
073449 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription No No AB 1993/09/23 WATSON LABS
071251 002 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription No No AB 1998/05/05 APOTEX INC
208360 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription No No AB 2018/06/29 ZYDUS PHARMS
216211 001 ANDA TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG Prescription No No AB 2022/02/23 RUBICON
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