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 |
|---|
| 1987/05/06 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2021/12/20 |
SUPPL-17（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/12/20 |
SUPPL-16（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 1998/12/09 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/03/26 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1996/10/03 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Microbiology-Processing |
|
|
|
| 1991/04/17 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1990/05/17 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/02/16 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
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:VERAPAMIL HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:5MG/2ML (2.5MG/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 |
|---|
| 018925 |
001 |
NDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
1984/03/30
|
EXELA PHARMA |
| 070737 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
Yes |
AP |
1987/05/06
|
HOSPIRA |
| 070738 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
Yes |
AP |
1987/05/06
|
HOSPIRA |
| 075136 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
Yes |
AP |
1998/10/20
|
HOSPIRA |
| 211015 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2018/06/18
|
SOMERSET THERAPS LLC |
| 211035 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2018/06/18
|
SOMERSET |
| 210994 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2018/07/13
|
AMNEAL |
| 211370 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2018/12/28
|
MICRO LABS |
| 213232 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2020/03/25
|
CAPLIN |
| 213352 |
002 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/2ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2020/09/16
|
NEPHRON |