药品注册申请号:013402
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK AND 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 ALDORIL 15 HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 15MG;250MG No No None 1962/12/20 Approved Prior to Jan 1, 1982 Discontinued
002 ALDORIL 25 HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 25MG;250MG No No None Approved Prior to Jan 1, 1982 Discontinued
003 ALDORIL D30 HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 30MG;500MG No No None Approved Prior to Jan 1, 1982 Discontinued
004 ALDORIL D50 HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 50MG;500MG No 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
2004/12/14 SUPPL 85 Approval Labeling STANDARD
2002/04/05 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1999/07/23 SUPPL 81 Approval Labeling STANDARD
1998/07/02 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1997/08/05 SUPPL 80 Approval Labeling STANDARD
1995/11/29 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1994/12/16 SUPPL 77 Approval Labeling STANDARD
1994/09/26 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1994/03/07 SUPPL 76 Approval Labeling STANDARD
1993/03/24 SUPPL 75 Approval Labeling STANDARD
1992/12/18 SUPPL 72 Approval Labeling STANDARD
1992/09/17 SUPPL 74 Approval Labeling STANDARD
1990/09/13 SUPPL 73 Approval Labeling STANDARD
1988/04/26 SUPPL 70 Approval Manufacturing (CMC) STANDARD
1988/04/21 SUPPL 71 Approval Labeling STANDARD
1987/08/26 SUPPL 69 Approval Labeling STANDARD
1987/05/08 SUPPL 56 Approval Labeling STANDARD
1986/06/02 SUPPL 68 Approval Labeling STANDARD
1985/10/24 SUPPL 67 Approval Labeling STANDARD
1985/01/17 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1984/11/15 SUPPL 65 Approval Labeling STANDARD
1984/08/13 SUPPL 64 Approval Labeling STANDARD
1984/04/10 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1984/04/03 SUPPL 63 Approval Labeling STANDARD
1984/01/23 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1983/12/23 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1983/03/01 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1982/09/08 SUPPL 57 Approval Labeling STANDARD
1982/04/19 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1981/10/14 SUPPL 55 Approval Labeling STANDARD
1981/08/28 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1981/06/17 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1981/05/11 SUPPL 52 Approval Labeling STANDARD
1981/04/09 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1981/03/04 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1981/01/23 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1980/11/14 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1980/01/11 SUPPL 47 Approval Labeling STANDARD
1980/01/03 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1979/10/31 SUPPL 45 Approval Labeling STANDARD
1979/10/31 SUPPL 44 Approval Labeling STANDARD
1979/10/31 SUPPL 32 Approval Labeling STANDARD
1979/03/09 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1978/11/07 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1978/08/29 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1978/06/26 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1978/06/26 SUPPL 37 Approval Labeling STANDARD
1978/02/15 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1977/10/25 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1977/09/13 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1977/09/13 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1977/09/13 SUPPL 34 Approval Labeling STANDARD
1976/11/09 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1976/08/31 SUPPL 30 Approval Labeling STANDARD
1976/03/19 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1975/06/12 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1962/12/20 ORIG 1 Approval Type 4 - New Combination STANDARD
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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