药品注册申请号:017354
申请类型:NDA (新药申请)
申请人:TEVA BRANDED PHARM
申请人全名:TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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 LOESTRIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Yes No AB 1973/04/30 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 51 Approval Labeling STANDARD
2016/01/14 SUPPL 48 Approval Manufacturing (CMC) PRIORITY
2014/09/26 SUPPL 47 Approval Manufacturing (CMC) PRIORITY
2014/08/01 SUPPL 46 Approval Manufacturing (CMC) PRIORITY
2014/07/31 SUPPL 45 Approval Manufacturing (CMC) PRIORITY
2003/05/02 SUPPL 44 Approval Labeling STANDARD
1999/11/24 SUPPL 42 Approval Labeling STANDARD
1999/03/31 SUPPL 43 Approval Labeling STANDARD
1999/01/08 SUPPL 41 Approval Labeling STANDARD
1998/01/16 SUPPL 40 Approval Labeling STANDARD
1997/11/20 SUPPL 39 Approval Manufacturing (CMC) PRIORITY
1997/07/28 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
1997/07/28 SUPPL 37 Approval Manufacturing (CMC) PRIORITY
1996/03/08 SUPPL 33 Approval Labeling STANDARD
1996/03/08 SUPPL 30 Approval Labeling
1995/07/07 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
1994/06/27 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
1994/06/02 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
1994/03/07 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1993/07/09 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1991/04/22 SUPPL 29 Approval Labeling
1989/05/17 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1988/09/13 SUPPL 26 Approval Labeling
1988/03/16 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1986/10/22 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1986/06/04 SUPPL 24 Approval Labeling
1985/09/17 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1984/10/22 SUPPL 23 Approval Labeling
1982/11/18 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1981/04/09 SUPPL 19 Approval Labeling
1978/06/14 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1977/11/22 SUPPL 17 Approval Labeling
1977/02/08 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1977/02/08 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1975/11/11 SUPPL 10 Approval Labeling
1973/04/30 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)
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-28 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
017354 001 NDA LOESTRIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription Yes No AB Approved Prior to Jan 1, 1982 TEVA BRANDED PHARM
075647 001 ANDA MICROGESTIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2001/02/05 MAYNE PHARMA
076081 001 ANDA JUNEL FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2003/09/18 BARR
077077 001 ANDA GILDESS FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2005/05/20 VINTAGE PHARMS LLC
091454 001 ANDA LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2013/08/26 NOVAST LABS
202772 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2013/11/14 MYLAN LABS LTD
201584 001 ANDA BLISOVI FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2015/11/18 LUPIN LTD
207505 001 ANDA AUROVELA FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2017/06/16 AUROBINDO PHARMA LTD
206597 001 ANDA HAILEY FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-28 0.02MG;1MG Prescription No No AB 2017/11/21 GLENMARK PHARMS LTD
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