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 |
|---|
| 2022/04/29 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/06/11 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/10/21 |
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; NORETHINDRONE 剂型/给药途径:TABLET;ORAL-28 规格:0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG 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 |
|---|
| 075478 |
002 |
ANDA |
NORTREL 7/7/7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG |
Prescription |
No |
No |
AB |
2002/08/30
|
BARR |
| 090946 |
001 |
ANDA |
DASETTA 7/7/7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG |
Prescription |
No |
Yes |
AB |
2011/12/22
|
NOVAST LABS LTD |
| 091636 |
001 |
ANDA |
ALYACEN 7/7/7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG |
Prescription |
No |
No |
AB |
2012/01/19
|
GLENMARK PHARMS LTD |
| 207054 |
001 |
ANDA |
NYLIA 7/7/7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG |
Prescription |
No |
No |
AB |
2016/10/21
|
AUROBINDO PHARMA |