药品注册申请号:075478
申请类型:ANDA (仿制药申请)
申请人:BARR
申请人全名:BARR LABORATORIES 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 NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG No No None 2002/08/30 2002/08/30 Prescription
002 NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG No No AB 2002/08/30 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
2016/08/26 SUPPL 17 Approval Labeling STANDARD
2015/01/20 SUPPL 15 Approval Labeling STANDARD
2014/12/31 SUPPL 13 Approval Labeling STANDARD
2004/04/20 SUPPL 3 Approval Labeling
2002/08/30 ORIG 1 Approval
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,0.035MG,0.035MG;0.5MG,0.75MG,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
018985 002 NDA ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription Yes Yes AB 1984/04/04 JANSSEN PHARMS
075478 002 ANDA NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2002/08/30 BARR
076338 001 ANDA CYCLAFEM 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2010/11/16 VINTAGE PHARMS LLC
090946 001 ANDA DASETTA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2011/12/22 NOVAST LABS LTD
091636 001 ANDA ALYACEN 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2012/01/19 GLENMARK GENERICS
201510 001 ANDA PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2013/04/24 LUPIN LTD
207054 001 ANDA NYLIA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2016/10/21 AUROBINDO PHARMA LTD
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