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 |
|---|
| 2023/11/16 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/16 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/27 |
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 |
|---|
| 无 |
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 规格:0.03MG,0.01MG;0.15MG,N/A 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 |
|---|
| 021840 |
001 |
NDA |
SEASONIQUE |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
Yes |
Yes |
AB |
2006/05/25
|
TEVA BRANDED PHARM |
| 078834 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2011/05/31
|
DR REDDYS LABS SA |
| 091467 |
001 |
ANDA |
DAYSEE |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2013/04/10
|
LUPIN LTD |
| 203163 |
001 |
ANDA |
ASHLYNA |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2015/02/23
|
GLENMARK PHARMS LTD |
| 200492 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2015/05/27
|
XIROMED |
| 203872 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2015/12/22
|
AMNEAL PHARMS |
| 206851 |
001 |
ANDA |
SIMPESSE |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2017/04/07
|
AUROBINDO PHARMA |
| 203770 |
001 |
ANDA |
JAIMIESS |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.03MG,0.01MG;0.15MG,N/A |
Prescription |
No |
No |
AB |
2017/12/27
|
XIROMED |