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 |
|---|
| 2022/12/21 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/05/26 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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:ARFORMOTEROL TARTRATE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.015MG BASE/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 |
|---|
| 021912 |
001 |
NDA |
BROVANA |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
Yes |
Yes |
AN |
2006/10/06
|
LUPIN |
| 207306 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2021/06/22
|
CIPLA |
| 213132 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Discontinued |
No |
No |
AN |
2021/06/22
|
GLENMARK PHARMS LTD |
| 213762 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2021/06/22
|
BE PHARMS |
| 200293 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2021/11/09
|
TEVA PHARMS USA |
| 213068 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/02/07
|
LUPIN |
| 214736 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/03/02
|
RITEDOSE CORP |
| 214779 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/05/10
|
ALEMBIC |
| 215385 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/05/26
|
SUN PHARM |
| 216128 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/11/15
|
MANKIND PHARMA |
| 216815 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2022/11/25
|
WILSHIRE PHARMS INC |
| 214901 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2024/04/02
|
AIPING PHARM INC |
| 216303 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2024/05/17
|
CF PHARMTECH |
| 215032 |
001 |
ANDA |
ARFORMOTEROL TARTRATE |
ARFORMOTEROL TARTRATE |
SOLUTION;INHALATION |
EQ 0.015MG BASE/2ML |
Prescription |
No |
No |
AN |
2024/06/03
|
DR REDDYS |