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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1997/12/18 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2022/04/29 |
SUPPL-28（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2022/02/22 |
SUPPL-27（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/08/09 |
SUPPL-25（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2007/04/03 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1998/06/08 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/02/10 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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-28; 规格:0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG; 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 |
|---|
| 074538 |
002 |
ANDA |
TRIVORA-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL-28 |
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Prescription |
No |
Yes |
AB |
1997/12/18
|
DR REDDYS LABS SA |
| 075809 |
002 |
ANDA |
ENPRESSE-28 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL-28 |
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Prescription |
No |
No |
AB |
2001/07/16
|
DURAMED PHARMS BARR |
| 090719 |
001 |
ANDA |
LEVONEST |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL-28 |
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Prescription |
No |
No |
AB |
2010/12/29
|
NOVAST LABS LTD |
| 077502 |
001 |
ANDA |
MYZILRA |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL-28 |
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Prescription |
No |
No |
AB |
2011/11/23
|
PH HEALTH |
| 200248 |
001 |
ANDA |
LEVONORGESTREL AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TABLET;ORAL-28 |
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Prescription |
No |
No |
AB |
2015/11/19
|
LUPIN LTD |
