药品注册申请号：214074
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS 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 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) No No AP 2020/07/20 2020/07/20 Prescription
002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) No No AP 2020/07/20 Prescription
003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) No No AP 2020/07/20 Prescription
004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) No No AP 2020/07/20 Prescription
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
2024/03/09 SUPPL-1（补充） Approval Labeling STANDARD
2020/07/20 ORIG-1（原始申请） Approval 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:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:40MG/20ML (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
020533 002 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
090194 005 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Discontinued No No AP 2014/09/23 HOSPIRA
205612 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
212808 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription No No AP 2020/04/09 CAPLIN
214074 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription No No AP 2020/07/20 HIKMA
218713 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Prescription No No AP 2024/07/30 KINDOS
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:150MG/30ML (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RLDRSTE Code产品号批准日期申请人
020533 008 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
078601 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2014/07/17 NAVINTA LLC
090194 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Discontinued No No AP 2014/09/23 HOSPIRA
203955 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2016/04/11 RISING
205612 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
212808 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2020/04/09 CAPLIN
214074 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2020/07/20 HIKMA
218713 005 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Prescription No No AP 2024/07/30 KINDOS
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:150MG/20ML (7.5MG/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RLDRSTE Code产品号批准日期申请人
020533 004 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
090194 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Discontinued No No AP 2014/09/23 HOSPIRA
205612 005 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 005 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
214074 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Prescription No No AP 2020/07/20 HIKMA
218713 006 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Prescription No No AP 2024/07/30 KINDOS
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:200MG/20ML (10MG/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
020533 011 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription Yes Yes AP 1996/09/24 FRESENIUS KABI USA
078601 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2014/07/17 NAVINTA LLC
090194 006 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Discontinued No No AP 2014/09/23 HOSPIRA
205612 007 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 007 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
212808 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2020/04/09 CAPLIN
214074 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2020/07/20 HIKMA
218713 007 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Prescription No No AP 2024/07/30 KINDOS
更多信息
药品NDC数据与药品包装、标签说明书
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