药品注册申请号:017566
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN SALES 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 BREVICON 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-21 0.035MG;0.5MG No No None 1974/12/26 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
2017/10/10 SUPPL 92 Approval Labeling STANDARD
2017/08/09 SUPPL 91 Approval Labeling STANDARD
2001/08/15 SUPPL 85 Approval Manufacturing (CMC) STANDARD
2000/02/14 SUPPL 83 Approval Manufacturing (CMC) STANDARD
2000/01/24 SUPPL 84 Approval Labeling STANDARD
1997/07/30 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1995/08/30 SUPPL 79 Approval Labeling STANDARD
1994/12/13 SUPPL 81 Approval Labeling STANDARD
1994/12/13 SUPPL 80 Approval Labeling STANDARD
1994/02/04 SUPPL 77 Approval Labeling
1992/07/31 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1990/11/02 SUPPL 73 Approval Labeling
1990/09/19 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1989/10/23 SUPPL 75 Approval Manufacturing (CMC) STANDARD
1989/02/22 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1987/10/26 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1986/07/17 SUPPL 71 Approval Labeling
1985/10/25 SUPPL 70 Approval Labeling
1985/04/16 SUPPL 69 Approval Labeling
1984/11/13 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1984/09/27 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1984/07/30 SUPPL 66 Approval Labeling
1984/05/16 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1984/05/07 SUPPL 63 Approval Labeling
1984/03/06 SUPPL 59 Approval Labeling
1983/07/26 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1983/07/26 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1983/06/13 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1982/07/29 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1982/01/11 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1980/12/18 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1980/12/18 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1980/10/14 SUPPL 14 Approval Labeling
1980/07/31 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1978/05/26 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1977/07/05 SUPPL 16 Approval Labeling
1977/07/05 SUPPL 15 Approval Labeling
1977/06/14 SUPPL 21 Approval Labeling
1977/06/14 SUPPL 20 Approval Labeling
1977/06/14 SUPPL 19 Approval Labeling
1976/05/16 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1975/05/16 SUPPL 8 Approval Labeling
1975/05/16 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1975/05/16 SUPPL 4 Approval Labeling
1975/05/16 SUPPL 1 Approval Labeling
1974/12/26 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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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