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 |
|---|
| 2024/06/26 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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: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
|
VIATRIS SPECIALTY |
| 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 |
| 216426 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2024/10/22
|
LEXENPHARM |
| 215907 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2025/01/30
|
DR REDDYS |
| 218308 |
001 |
ANDA |
FORMOTEROL FUMARATE |
FORMOTEROL FUMARATE |
SOLUTION;INHALATION |
0.02MG/2ML |
Prescription |
No |
No |
AN |
2025/02/11
|
DEVA HOLDING AS |