药品注册申请号：019734
申请类型：NDA (新药申请)
申请人：CHIESI
申请人全名：CHIESI USA INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 CARDENE NICARDIPINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1992/01/30 1992/01/30 Discontinued
002 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE INJECTABLE;INTRAVENOUS 20MG/200ML (0.1MG/ML) Yes Yes None 2008/07/31 Prescription
003 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE INJECTABLE;INTRAVENOUS 20MG/200ML (0.1MG/ML) Yes Yes AP 2008/07/31 Prescription
004 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE INJECTABLE;INTRAVENOUS 40MG/200ML (0.2MG/ML) Yes Yes AP 2008/11/07 Prescription
005 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER NICARDIPINE HYDROCHLORIDE INJECTABLE;INTRAVENOUS 40MG/200ML (0.2MG/ML) Yes No None 2008/11/07 Discontinued
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
1992/01/30 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
2025/02/21 SUPPL-34（补充） Approval Labeling-Container/Carton Labels STANDARD
2022/09/16 SUPPL-31（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2018/07/27 SUPPL-30（补充） Approval Labeling-Package Insert STANDARD
2016/08/26 SUPPL-27（补充） Approval Labeling-Package Insert STANDARD
2015/12/21 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2015/05/21 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2014/12/02 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
2014/07/23 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2014/04/30 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2013/09/27 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2013/05/02 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2011/02/07 SUPPL-17（补充） Approval Labeling-Package Insert STANDARD
2010/01/13 SUPPL-15（补充） Approval Labeling STANDARD
2008/11/07 SUPPL-14（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
2008/07/31 SUPPL-13（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2007/06/22 SUPPL-9（补充） Approval Labeling STANDARD
2002/10/24 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/29 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1995/05/12 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1995/04/10 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/11/20 SUPPL-1（补充） Approval Manufacturing (CMC)-Control 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
002 10758616 2027/04/18 Y 2020/09/29 PDF格式
11547758 2027/04/18 U-1029 2023/02/09 PDF格式
7612102 2027/12/26 Y PDF格式
7659291 2027/04/18 U-1029 PDF格式
8455524 2027/04/18 U-1029 2013/06/27 PDF格式
9364564 2027/12/26 Y 2016/07/08 PDF格式
003 10758616 2027/04/18 Y 2020/09/29 PDF格式
11547758 2027/04/18 U-1029 2023/02/09 PDF格式
7612102 2027/12/26 Y PDF格式
7659291 2027/04/18 U-1029 PDF格式
8455524 2027/04/18 U-1029 PDF格式
9364564 2027/12/26 Y 2016/07/08 PDF格式
004 10758616 2027/04/18 Y 2020/09/29 PDF格式
11547758 2027/04/18 U-1029 2023/02/09 PDF格式
7612102 2027/12/26 Y PDF格式
7659291 2027/04/18 U-1029 PDF格式
8455524 2027/04/18 U-1029 PDF格式
9364564 2027/12/26 Y 2016/07/08 PDF格式
005 7612102 2027/12/26 Y PDF格式
7659291 2027/04/18 U-1029 PDF格式
8455524 2027/04/18 U-1029 PDF格式
9364564 2027/12/26 Y 2016/07/08 PDF格式
001 4880823 2006/11/14 PDF格式**本条是由Drugfuture回溯的历史信息**
5164405 2009/11/17 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
>>>活性成分:NICARDIPINE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;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RLDRSTE 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RLDRSTE 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
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