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 |
2024/02/22 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/02/22 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/07/17 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/08/17 |
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 |
无 |
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 | RLD | RS | TE 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 |