药品注册申请号:018303
申请类型:NDA (新药申请)
申请人:VALIDUS PHARMS
申请人全名:VALIDUS 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 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Yes No AB 1984/12/31 1984/12/31 Prescription
002 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/31 Discontinued
003 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/12/31 Discontinued
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
2023/12/22 SUPPL-42(补充) Approval Labeling STANDARD
2022/05/03 SUPPL-40(补充) Approval Labeling STANDARD
2020/08/20 SUPPL-41(补充) Approval Labeling STANDARD
2011/03/15 SUPPL-36(补充) Approval Labeling UNKNOWN
2011/03/15 SUPPL-35(补充) Approval Labeling UNKNOWN
2009/08/07 SUPPL-34(补充) Approval Labeling STANDARD
2008/07/24 SUPPL-33(补充) Approval Labeling STANDARD
2008/01/08 SUPPL-32(补充) Approval Labeling STANDARD
2006/09/07 SUPPL-29(补充) Approval Labeling STANDARD
2003/10/31 SUPPL-25(补充) Approval Labeling STANDARD
2002/06/14 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2002/04/29 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2002/02/08 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2001/07/30 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2000/05/12 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2000/05/10 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1999/04/28 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1999/02/18 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1997/11/07 SUPPL-16(补充) Approval Labeling STANDARD
1997/01/08 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1996/06/07 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1995/07/31 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1995/02/02 SUPPL-11(补充) Approval Labeling STANDARD
1991/11/08 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1991/09/18 SUPPL-9(补充) Approval Labeling
1990/06/14 SUPPL-8(补充) Approval Labeling
1988/12/09 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1988/09/23 SUPPL-5(补充) Approval Labeling
1988/05/31 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1985/10/23 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1985/03/26 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1985/02/22 SUPPL-2(补充) Approval Labeling
1984/12/31 ORIG-1(原始申请) Approval Type 4 - New Combination 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:HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 剂型/给药途径:TABLET;ORAL 规格:25MG;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
018303 001 NDA LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Prescription Yes No AB 1984/12/31 VALIDUS PHARMS
076792 001 ANDA METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Prescription No No AB 2004/08/20 MYLAN
090654 001 ANDA METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Discontinued No No AB 2012/01/19 SUN PHARM INDS
202870 001 ANDA METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Prescription No No AB 2013/11/06 ALEMBIC
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