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 |
|---|
| 2024/02/27 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/06/21 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/07 |
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 ACETATE 剂型/给药途径:TABLET;ORAL 规格:0.02MG;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 |
|---|
| 078267 |
001 |
ANDA |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Discontinued |
No |
No |
AB |
2009/09/01
|
AMNEAL PHARMS |
| 090293 |
001 |
ANDA |
GILDESS 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2014/12/01
|
ENDO OPERATIONS |
| 090938 |
001 |
ANDA |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2014/12/01
|
BARR LABS INC |
| 202994 |
001 |
ANDA |
LARIN 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2015/02/18
|
NOVAST LABS |
| 091398 |
001 |
ANDA |
BLISOVI 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2015/10/28
|
LUPIN LTD |
| 206287 |
001 |
ANDA |
MIBELAS 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2016/05/24
|
LUPIN |
| 207504 |
001 |
ANDA |
AUROVELA 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2017/06/15
|
AUROBINDO PHARMA |
| 204847 |
001 |
ANDA |
HAILEY 24 FE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
Yes |
AB |
2017/11/17
|
GLENMARK PHARMS LTD |
| 210369 |
001 |
ANDA |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
Yes |
AB |
2017/12/26
|
GLENMARK PHARMS LTD |
| 209609 |
001 |
ANDA |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2018/07/16
|
XIROMED |
| 210087 |
001 |
ANDA |
FINZALA |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Prescription |
No |
No |
AB |
2020/04/07
|
TEVA PHARMS USA INC |
| 216558 |
001 |
ANDA |
OSHIH |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
TABLET;ORAL |
0.02MG;1MG |
Discontinued |
No |
No |
AB |
2023/12/06
|
AUROBINDO PHARMA |