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 |
|---|
| 2023/03/08 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/03/08 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/03/22 |
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:LEVALBUTEROL HYDROCHLORIDE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.0103% BASE 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 |
|---|
| 020837 |
003 |
NDA |
XOPENEX |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Discontinued |
Yes |
No |
AN |
2002/01/30
|
HIKMA |
| 077756 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
No |
AN |
2008/04/09
|
IMPAX LABS INC |
| 090297 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
Yes |
AN |
2013/04/26
|
TEVA PHARMS USA |
| 078171 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
No |
AN |
2013/12/13
|
CIPLA |
| 203653 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
No |
AN |
2016/03/22
|
RITEDOSE CORP |
| 207625 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
No |
AN |
2016/12/30
|
LUOXIN AUROVITAS |
| 207820 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.0103% BASE |
Prescription |
No |
No |
AN |
2018/11/05
|
SUN PHARM |
活性成分:LEVALBUTEROL HYDROCHLORIDE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.021% BASE 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 |
|---|
| 020837 |
001 |
NDA |
XOPENEX |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Discontinued |
Yes |
No |
AN |
1999/03/25
|
HIKMA |
| 077756 |
001 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
No |
AN |
2008/04/09
|
IMPAX LABS INC |
| 090297 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
Yes |
AN |
2013/04/26
|
TEVA PHARMS USA |
| 078171 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
No |
AN |
2013/12/13
|
CIPLA |
| 203653 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
No |
AN |
2016/03/22
|
RITEDOSE CORP |
| 207625 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
No |
AN |
2016/12/30
|
LUOXIN AUROVITAS |
| 207820 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.021% BASE |
Prescription |
No |
No |
AN |
2018/11/05
|
SUN PHARM |
活性成分:LEVALBUTEROL HYDROCHLORIDE 剂型/给药途径:SOLUTION;INHALATION 规格:EQ 0.042% BASE 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 |
|---|
| 020837 |
002 |
NDA |
XOPENEX |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Discontinued |
Yes |
No |
AN |
1999/03/25
|
HIKMA |
| 077756 |
002 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
No |
AN |
2008/04/09
|
IMPAX LABS INC |
| 090297 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
Yes |
AN |
2013/04/26
|
TEVA PHARMS USA |
| 078171 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
No |
AN |
2013/12/13
|
CIPLA |
| 203653 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
No |
AN |
2016/03/22
|
RITEDOSE CORP |
| 207625 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
No |
AN |
2016/12/30
|
LUOXIN AUROVITAS |
| 207820 |
003 |
ANDA |
LEVALBUTEROL HYDROCHLORIDE |
LEVALBUTEROL HYDROCHLORIDE |
SOLUTION;INHALATION |
EQ 0.042% BASE |
Prescription |
No |
No |
AN |
2018/11/05
|
SUN PHARM |