药品注册申请号:017743
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 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG No No AB 1976/03/29 Approved Prior to Jan 1, 1982 Prescription
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 89 Approval Labeling STANDARD
2017/08/09 SUPPL 88 Approval Labeling STANDARD
2001/08/15 SUPPL 75 Approval Manufacturing (CMC) STANDARD
2000/02/14 SUPPL 73 Approval Manufacturing (CMC) STANDARD
2000/01/24 SUPPL 74 Approval Labeling STANDARD
1999/02/04 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1997/07/30 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1995/08/30 SUPPL 69 Approval Labeling STANDARD
1994/12/13 SUPPL 70 Approval Labeling STANDARD
1994/02/04 SUPPL 67 Approval Labeling
1992/07/31 SUPPL 68 Approval Manufacturing (CMC) STANDARD
1990/11/02 SUPPL 63 Approval Labeling
1990/09/19 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1989/10/20 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1989/02/22 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1987/10/26 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1986/07/17 SUPPL 61 Approval Labeling
1985/10/25 SUPPL 60 Approval Labeling
1985/04/16 SUPPL 59 Approval Labeling
1984/11/13 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1984/09/27 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1984/07/30 SUPPL 56 Approval Labeling
1984/06/12 SUPPL 55 Approval Labeling
1984/05/16 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1984/05/07 SUPPL 52 Approval Labeling
1984/03/06 SUPPL 48 Approval Labeling
1983/07/26 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1983/07/26 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1983/06/13 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1982/07/29 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1982/01/11 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1980/12/18 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1980/12/18 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1980/10/14 SUPPL 3 Approval Labeling
1980/06/23 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1978/05/26 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1977/07/01 SUPPL 4 Approval Labeling
1977/06/14 SUPPL 8 Approval Labeling
1977/06/14 SUPPL 7 Approval Labeling
1976/03/29 ORIG 1 Approval Type 3 - New Dosage Form 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:ETHINYL ESTRADIOL; NORETHINDRONE 剂型/给药途径:TABLET;ORAL-28 规格:0.035MG;0.5MG 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
017743 001 NDA BREVICON 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No No AB Approved Prior to Jan 1, 1982 ALLERGAN
070686 001 ANDA NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No No AB 1987/01/29 MAYNE PHARMA
072695 001 ANDA NORTREL 0.5/35-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No No AB 1992/02/28 BARR
091204 001 ANDA WERA ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No Yes AB 2012/03/27 NOVAST LABS LTD
203413 001 ANDA CYCLAFEM 0.5/35 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No No AB 2015/12/16 VINTAGE PHARMS
207055 001 ANDA CYONANZ ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;0.5MG Prescription No No AB 2016/10/21 AUROBINDO PHARMA LTD
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