药品注册申请号:211944
申请类型:ANDA (仿制药申请)
申请人:HETERO LABS
申请人全名:HETERO LABS 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 DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG No No AB 2019/03/22 2019/03/22 Prescription
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
2023/08/16 SUPPL-5(补充) Approval Labeling STANDARD
2023/08/16 SUPPL-2(补充) Approval Labeling STANDARD
2019/03/22 ORIG-1(原始申请) Approval 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:DROSPIRENONE; ETHINYL ESTRADIOL 剂型/给药途径:TABLET;ORAL 规格:3MG;0.02MG 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
021676 001 NDA YAZ DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription Yes Yes AB 2006/03/16 BAYER HLTHCARE
078515 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Discontinued No No AB 2009/03/30 BARR
079221 001 ANDA LORYNA DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2011/03/28 XIROMED
078833 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2011/11/28 WATSON LABS
201661 001 ANDA NIKKI DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2014/05/27 LUPIN LTD
204296 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2015/08/17 GLENMARK PHARMS LTD
202594 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2015/10/22 XIROMED
202016 001 ANDA MELAMISA DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2016/01/26 NOVAST LABS
203291 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2017/07/18 HLTHCARE
209632 001 ANDA LO-ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2018/02/27 AUROBINDO PHARMA LTD
211944 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL 3MG;0.02MG Prescription No No AB 2019/03/22 HETERO LABS
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