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 |
|---|
| 2025/10/28 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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:NICARDIPINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:25MG/10ML (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 |
|---|
| 022276 |
001 |
NDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2008/07/24
|
HIKMA INTL PHARMS |
| 078405 |
001 |
NDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Discontinued |
No |
No |
AP |
2009/11/17
|
SUN PHARM |
| 090534 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
Yes |
AP |
2009/11/17
|
AM REGENT |
| 090664 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2009/11/17
|
RK PHARMA |
| 090671 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2009/11/17
|
MANKIND PHARMA |
| 211121 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2021/04/08
|
EUGIA PHARMA |
| 216420 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2023/07/07
|
MICRO LABS |
| 217548 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2024/09/06
|
CHENGDU SHUODE |
| 215406 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Discontinued |
No |
No |
AP |
2024/10/31
|
AMNEAL |
| 216819 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2025/08/20
|
NANJING KING FRIEND |
| 219608 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/10ML (2.5MG/ML) |
Prescription |
No |
No |
AP |
2025/10/28
|
QILU PHARM HAINAN |