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 |
|---|
| 2008/07/24 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |
|---|
| 2025/06/27 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC)-Control |
N/A
|
|
|
| 2024/08/16 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Packaging |
N/A
|
|
|
| 2022/01/07 |
SUPPL-20（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2021/06/01 |
SUPPL-18（补充） |
Approval |
Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2016/09/23 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/04/07 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/10/28 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/01/10 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2009/01/08 |
SUPPL-3（补充） |
Approval |
Labeling |
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: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 |
>>>活性成分:NICARDIPINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:20MG/200ML (0.1MG/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 |
|---|
| 019734 |
003 |
NDA |
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Prescription |
Yes |
Yes |
AP |
2008/07/31
|
CHIESI |
| 022276 |
002 |
NDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Prescription |
Yes |
Yes |
AP |
2016/04/07
|
HIKMA INTL PHARMS |
| 203978 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2024/04/17
|
INFORLIFE |
| 215592 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2024/09/24
|
CIPLA |
| 220243 |
001 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
20MG/200ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2025/10/22
|
CAPLIN |
>>>活性成分:NICARDIPINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:40MG/200ML (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 |
|---|
| 019734 |
004 |
NDA |
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Prescription |
Yes |
Yes |
AP |
2008/11/07
|
CHIESI |
| 022276 |
003 |
NDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Prescription |
Yes |
Yes |
AP |
2016/04/07
|
HIKMA INTL PHARMS |
| 203978 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Prescription |
No |
No |
AP |
2024/04/17
|
INFORLIFE |
| 215592 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Prescription |
No |
No |
AP |
2024/09/24
|
CIPLA |
| 220243 |
002 |
ANDA |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
NICARDIPINE HYDROCHLORIDE |
INJECTABLE;INTRAVENOUS |
40MG/200ML (0.2MG/ML) |
Prescription |
No |
No |
AP |
2025/10/22
|
CAPLIN |
