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 |
|---|
| 2002/04/05 |
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 |
|---|
| 2024/06/10 |
SUPPL-37（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert,Labeling |
STANDARD
|
|
|
| 2024/06/10 |
SUPPL-35（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2022/04/29 |
SUPPL-34（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2017/08/09 |
SUPPL-26（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2013/02/28 |
SUPPL-21（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2013/02/28 |
SUPPL-20（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2009/09/24 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 2002/10/04 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2002/10/04 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
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:DESOGESTREL; ETHINYL ESTRADIOL; 剂型/给药途径:TABLET;ORAL-28; 规格:0.15MG,N/A;0.02MG,0.01MG; 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 |
|---|
| 075863 |
001 |
ANDA |
KARIVA |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
Yes |
AB |
2002/04/05
|
BARR |
| 091346 |
001 |
ANDA |
VIORELE |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2012/04/02
|
GLENMARK PHARMS LTD |
| 091247 |
001 |
ANDA |
PIMTREA |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2013/08/01
|
NOVAST LABS |
| 202296 |
001 |
ANDA |
DESOGESTREL AND ETHINYL ESTRADIOL |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2013/08/30
|
XIROMED |
| 076681 |
001 |
ANDA |
KIMIDESS |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Discontinued |
No |
No |
AB |
2015/04/30
|
PH HEALTH |
| 202226 |
001 |
ANDA |
BEKYREE |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2015/08/12
|
LUPIN LTD |
| 202689 |
001 |
ANDA |
VOLNEA |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2016/09/09
|
XIROMED |
| 206853 |
001 |
ANDA |
SIMLIYA |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2017/03/22
|
AUROBINDO PHARMA |
| 209170 |
001 |
ANDA |
DESOGESTREL AND ETHINYL ESTRADIOL |
DESOGESTREL; ETHINYL ESTRADIOL |
TABLET;ORAL-28 |
0.15MG,N/A;0.02MG,0.01MG |
Prescription |
No |
No |
AB |
2017/06/05
|
NAARI PTE |
