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 |
2019/05/29 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/10/17 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/30 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/03/19 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/09/25 |
SUPPL-8(补充) |
Approval |
REMS |
N/A
|
|
|
2012/09/25 |
SUPPL-7(补充) |
Approval |
REMS |
N/A
|
|
|
2012/01/11 |
SUPPL-6(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/02/01 |
SUPPL-5(补充) |
Approval |
REMS |
N/A
|
|
|
2010/06/02 |
SUPPL-4(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2007/05/11 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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:FORMOTEROL FUMARATE 剂型/给药途径:SOLUTION;INHALATION 规格:0.02MG/2ML 治疗等效代码:AN
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 |
022007 |
001 |
NDA |
PERFOROMIST |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
Yes |
Yes |
AN |
2007/05/11
|
MYLAN SPECLT |
091141 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2021/06/22
|
TEVA PHARMS USA INC |
215078 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2021/11/22
|
ALEMBIC |
215053 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2022/08/22
|
LUPIN |
216486 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2022/11/25
|
RITEDOSE CORP |
215621 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2022/12/13
|
WILSHIRE PHARMS INC |
215883 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2023/03/22
|
MANKIND PHARMA |
218304 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2024/06/26
|
MICRO LABS |