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-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/02/15 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/02/15 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/29 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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; NORGESTIMATE 剂型/给药途径:TABLET;ORAL-28 规格:0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG 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 |
|---|
| 076784 |
001 |
ANDA |
TRI LO SPRINTEC |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2009/06/29
|
BARR LABS INC |
| 200541 |
001 |
ANDA |
NORGESTIMATE AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2012/06/25
|
LUPIN PHARMS |
| 091232 |
001 |
ANDA |
TRI-LO-ESTARYLLA |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2015/06/29
|
XIROMED |
| 204057 |
001 |
ANDA |
NORGESTIMATE AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
Yes |
AB |
2016/02/23
|
GLENMARK SPECLT |
| 203873 |
001 |
ANDA |
NORGESTIMATE AND ETHINYL ESTRADIOL |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2016/05/12
|
AMNEAL PHARMS |
| 205762 |
001 |
ANDA |
TRI-LO-MILI |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2016/11/04
|
AUROBINDO PHARMA |
| 090541 |
001 |
ANDA |
TRI-LO-LINYAH |
ETHINYL ESTRADIOL; NORGESTIMATE |
TABLET;ORAL-28 |
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG |
Prescription |
No |
No |
AB |
2022/09/02
|
NOVAST LABS |