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 |
|---|
| 2023/09/05 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/12 |
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:ISOPROTERENOL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.2MG/ML 治疗等效代码:AP
| 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 |
|---|
| 206961 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
Yes |
AP |
2017/08/02
|
NEXUS |
| 210322 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2018/06/12
|
CIPLA |
| 210106 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2018/06/18
|
AMPHASTAR PHARMS INC |
| 210576 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2018/10/17
|
AMNEAL |
| 211864 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/02/09
|
EUGIA PHARMA |
| 210845 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/02/16
|
MICRO LABS |
| 211237 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/05/19
|
AMRING PHARMS |
| 212189 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/11/19
|
AVET LIFESCIENCES |
| 212573 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2022/09/06
|
MYLAN LABS LTD |
| 215542 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2022/09/20
|
PENN LIFE |
| 214775 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2022/10/19
|
AM REGENT |
| 215557 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2023/04/14
|
ZYDUS PHARMS |
| 211703 |
001 |
ANDA |
ISOPROTERENOL HYDROCHLORIDE |
ISOPROTERENOL HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2023/04/26
|
HIKMA |