药品注册申请号:075796
申请类型:ANDA (仿制药申请)
申请人:DURAMED PHARMS BARR
申请人全名:DURAMED PHARMACEUTICALS INC SUB 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 AVIANE-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG No No AB1 2001/04/30 2001/04/30 Prescription
002 AVIANE-21 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-21 0.02MG;0.1MG No No None 2001/04/30 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
2017/08/09 SUPPL 22 Approval Labeling STANDARD
2010/03/30 SUPPL 17 Approval Labeling
2002/06/19 SUPPL 5 Approval Manufacturing (CMC)
2002/05/15 SUPPL 4 Approval Manufacturing (CMC)
2002/05/03 SUPPL 3 Approval Manufacturing (CMC)
2001/10/31 SUPPL 1 Approval Manufacturing (CMC)
2001/04/30 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; LEVONORGESTREL 剂型/给药途径:TABLET;ORAL-28 规格:0.02MG;0.1MG 治疗等效代码:AB1
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
075796 001 ANDA AVIANE-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2001/04/30 DURAMED PHARMS BARR
076625 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No Yes AB1 2004/11/18 MAYNE PHARMA
090721 001 ANDA FALMINA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2012/03/28 NOVAST LABS LTD
091425 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2013/01/18 LUPIN LTD
200245 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2013/10/09 MYLAN LABS LTD
201108 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2014/02/05 AMNEAL PHARMS
201088 001 ANDA VIENVA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2015/05/21 XIROMED
206886 001 ANDA AFIRMELLE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2016/11/14 AUROBINDO PHARMA LTD
202817 001 ANDA CERINTA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2019/01/07 SUN PHARM
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