药品注册申请号:017876
申请类型:NDA (新药申请)
申请人:APIL
申请人全名:ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
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 LOESTRIN 21 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Yes No AB 1976/10/01 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
2017/08/09 SUPPL 36 Approval Labeling STANDARD
2014/09/26 SUPPL 33 Approval Manufacturing (CMC) STANDARD
2003/05/02 SUPPL 31 Approval Labeling STANDARD
1999/11/24 SUPPL 29 Approval Labeling STANDARD
1999/03/31 SUPPL 30 Approval Labeling STANDARD
1999/01/08 SUPPL 28 Approval Labeling STANDARD
1998/01/16 SUPPL 27 Approval Labeling STANDARD
1997/11/20 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1997/07/28 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1997/07/28 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1996/03/08 SUPPL 20 Approval Labeling STANDARD
1996/03/08 SUPPL 17 Approval Labeling
1995/07/07 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1994/06/27 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1994/06/02 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1994/03/07 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1993/07/09 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1991/04/22 SUPPL 16 Approval Labeling
1989/05/17 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1988/09/13 SUPPL 13 Approval Labeling
1988/03/16 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1986/06/04 SUPPL 12 Approval Labeling
1985/09/17 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 11 Approval Labeling
1982/11/18 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1978/06/14 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1977/11/10 SUPPL 5 Approval Labeling
1977/02/09 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1977/02/09 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1976/10/01 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 ACETATE 剂型/给药途径:TABLET;ORAL-21 规格:0.02MG;1MG 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
017876 001 NDA LOESTRIN 21 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription Yes No AB Approved Prior to Jan 1, 1982 APIL
076380 001 ANDA JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2003/05/30 BARR
075647 002 ANDA MICROGESTIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2003/07/30 MAYNE PHARMA
077077 002 ANDA GILDESS 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2012/07/24 VINTAGE PHARMS LLC
202771 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2013/11/06 MYLAN LABS LTD
202995 001 ANDA LARIN 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2013/12/04 NOVAST LABS
206969 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2016/01/20 GLENMARK PHARMS LTD
207506 001 ANDA AUROVELA 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.02MG;1MG Prescription No No AB 2017/06/16 AUROBINDO PHARMA LTD
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