药品注册申请号:018017
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK RESEARCH LABORATORIES DIV MERCK CO 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001 BLOCADREN TIMOLOL MALEATE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1981/11/25 Approved Prior to Jan 1, 1982 Discontinued
002 BLOCADREN TIMOLOL MALEATE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 BLOCADREN TIMOLOL MALEATE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2009/03/13 SUPPL 16 Approval Efficacy
2009/03/13 SUPPL 8 Approval Efficacy
2009/03/13 SUPPL 4 Approval Efficacy
2003/02/25 SUPPL 36 Approval Labeling STANDARD
2002/03/27 SUPPL 37 Approval Labeling STANDARD
2001/12/17 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
1998/05/15 SUPPL 33 Approval Labeling STANDARD
1998/05/04 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1998/02/13 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1997/04/18 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1997/04/18 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1994/02/09 SUPPL 28 Approval Labeling STANDARD
1991/04/17 SUPPL 26 Approval Labeling
1990/03/08 SUPPL 11 Approval Efficacy
1989/06/05 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1988/08/15 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1987/12/11 SUPPL 20 Approval Labeling
1987/06/01 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1987/03/24 SUPPL 23 Approval Labeling
1987/03/24 SUPPL 18 Approval Labeling
1986/08/12 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1985/08/08 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1985/02/25 SUPPL 15 Approval Labeling
1985/02/25 SUPPL 14 Approval Efficacy
1985/01/02 SUPPL 17 Approval Labeling
1983/12/23 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1983/09/23 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1983/08/29 SUPPL 13 Approval Labeling
1983/08/29 SUPPL 12 Approval Labeling
1983/07/22 SUPPL 6 Approval Labeling
1982/09/20 SUPPL 7 Approval Labeling
1982/09/20 SUPPL 1 Approval Labeling
1982/05/07 SUPPL 3 Approval Labeling
1982/04/09 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1982/03/03 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1981/11/25 ORIG 1 Approval Type 3 - New Dosage Form PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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