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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2022/04/29 SUPPL-28(补充) Approval Labeling STANDARD
2022/02/17 SUPPL-24(补充) Approval Labeling STANDARD
2017/08/09 SUPPL-22(补充) Approval Labeling STANDARD
2010/03/30 SUPPL-17(补充) Approval Labeling
2002/06/19 SUPPL-5(补充) Approval Manufacturing (CMC)
2002/05/15 SUPPL-4(补充) Approval Manufacturing (CMC)
2002/05/03 SUPPL-3(补充) Approval Manufacturing (CMC)
2001/10/31 SUPPL-1(补充) Approval Manufacturing (CMC)
2001/04/30 ORIG-1(原始申请) 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 DR REDDYS LABS SA
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 XIROMED
201108 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Discontinued 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
207065 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2020/08/17 NAARI PTE LTD
212298 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.02MG;0.1MG Prescription No No AB1 2023/02/13 HETERO LABS
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