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 |
|---|
| 2024/10/28 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/04/26 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/06/30 |
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:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/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 |
|---|
| 040136 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
1997/06/30
|
AM REGENT |
| 040388 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
Yes |
AP |
2001/03/13
|
FRESENIUS KABI USA |
| 040730 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2009/04/21
|
RISING |
| 202938 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2013/03/28
|
NAVINTA LLC |
| 203110 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2015/06/29
|
ADRASTEA PHARMA |
| 204680 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Discontinued |
No |
No |
AP |
2016/04/28
|
NORVIUM BIOSCIENCE |
| 213667 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2020/12/18
|
HIKMA |
| 215147 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/ML |
Prescription |
No |
No |
AP |
2023/02/13
|
EUGIA PHARMA |
