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 |
|---|
| 2023/01/27 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/01/27 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/04/29 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/09 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/07 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2008/10/24 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
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:0.02MG,0.1MG;0.01MG,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 |
|---|
| 022262 |
001 |
NDA |
LOSEASONIQUE |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Prescription |
No |
No |
AB |
2008/10/24
|
TEVA BRANDED PHARM |
| 200407 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Discontinued |
No |
No |
AB |
2011/10/25
|
DR REDDYS LABS SA |
| 091674 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Prescription |
No |
No |
AB |
2011/10/26
|
LUPIN LTD |
| 200493 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Prescription |
No |
No |
AB |
2015/06/17
|
XIROMED |
| 206852 |
001 |
ANDA |
LO SIMPESSE |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Prescription |
No |
No |
AB |
2017/04/28
|
AUROBINDO PHARMA |
| 205131 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL |
0.02MG,0.1MG;0.01MG,N/A |
Prescription |
No |
No |
AB |
2017/12/14
|
XIROMED |
