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 |
2023/06/26 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/04/29 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/09 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/11 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/08/12 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/08/12 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/13 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/12/22 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:ETHINYL ESTRADIOL; NORETHINDRONE 剂型/给药途径:TABLET, CHEWABLE;ORAL 规格:0.025MG;0.8MG 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 |
022573 |
001 |
NDA |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET, CHEWABLE;ORAL |
0.025MG;0.8MG |
Prescription |
Yes |
Yes |
AB |
2010/12/22
|
TEVA BRANDED PHARM |
203371 |
001 |
ANDA |
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET, CHEWABLE;ORAL |
0.025MG;0.8MG |
Prescription |
No |
No |
AB |
2014/04/23
|
XIROMED |
203448 |
001 |
ANDA |
KAITLIB FE |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET, CHEWABLE;ORAL |
0.025MG;0.8MG |
Prescription |
No |
No |
AB |
2015/12/17
|
LUPIN LTD |