药品注册申请号:021098
申请类型:NDA (新药申请)
申请人:BAYER HLTHCARE
申请人全名:BAYER HEALTHCARE PHARMACEUTICALS 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 YASMIN DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Yes Yes AB 2001/05/11 2001/05/11 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
2023/05/19 SUPPL-29(补充) Approval Labeling STANDARD
2022/04/29 SUPPL-30(补充) Approval Labeling STANDARD
2017/08/09 SUPPL-28(补充) Approval Labeling STANDARD
2016/03/08 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2015/06/01 SUPPL-23(补充) Approval Labeling STANDARD
2014/11/26 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2014/09/30 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2013/01/31 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2012/04/10 SUPPL-22(补充) Approval Labeling STANDARD
2012/02/13 SUPPL-19(补充) Approval Efficacy STANDARD
2010/04/07 SUPPL-17(补充) Approval Labeling UNKNOWN
2003/05/09 SUPPL-5(补充) Approval Efficacy STANDARD
2002/08/08 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2001/12/12 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
2001/11/30 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2001/11/30 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2001/11/26 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
2001/05/11 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity and Type 4 - New Combination 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
001 5569652 2013/10/29 U-1 PDF格式**本条是由Drugfuture回溯的历史信息**
6787531 2020/08/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6933395 2017/08/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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-28 规格:3MG;0.03MG 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
021098 001 NDA YASMIN DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription Yes Yes AB 2001/05/11 BAYER HLTHCARE
077527 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Discontinued No No AB 2008/05/09 BARR
090081 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2010/09/07 DR REDDYS LABS SA
090114 001 ANDA SYEDA DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2011/03/28 XIROMED
201663 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2012/12/18 LUPIN LTD
202015 001 ANDA YAELA DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2014/11/19 NOVAST LABS
202131 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2015/05/04 XIROMED
204848 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2016/03/25 GLENMARK PHARMS LTD
207245 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2016/11/22 NAARI PTE LTD
209407 001 ANDA ZUMANDIMINE DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2018/03/26 AUROBINDO PHARMA LTD
213034 001 ANDA DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL-28 3MG;0.03MG Prescription No No AB 2020/01/24 HETERO LABS
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