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 | RLD | RS | TE 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 |
