药品注册申请号：206166
申请类型：ANDA (仿制药申请)
申请人：INFORLIFE
申请人全名：INFORLIFE SA
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 200MG/100ML (2MG/ML) No No AP 2018/06/11 2018/06/11 Prescription
002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) No No AP 2018/06/11 Prescription
003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) No No AP 2018/06/11 Prescription
004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 1GM/200ML (5MG/ML) No No AP 2018/06/11 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
2023/08/29 SUPPL-10（补充） Approval Labeling STANDARD
2019/11/14 SUPPL-3（补充） Approval Labeling STANDARD
2018/06/11 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:200MG/100ML (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 006 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
205612 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
204636 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2018/03/16 RISING
206166 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2018/06/11 INFORLIFE
210102 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2022/08/18 GLAND PHARMA LTD
216605 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2023/03/08 AMNEAL
206091 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2023/10/26 MYLAN LABS LTD
212808 005 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2024/05/23 CAPLIN
211907 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Prescription No No AP 2024/08/15 HIKMA
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:400MG/200ML (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 007 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
204636 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2018/03/16 RISING
206166 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2018/06/11 INFORLIFE
210102 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2022/08/18 GLAND PHARMA LTD
216605 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2023/03/08 AMNEAL
206091 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2023/10/26 MYLAN LABS LTD
212808 006 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2024/05/23 CAPLIN
211907 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Prescription No No AP 2024/08/15 HIKMA
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:500MG/100ML (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 009 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) Prescription Yes No AP 2011/01/04 FRESENIUS KABI USA
206166 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) Prescription No No AP 2018/06/11 INFORLIFE
216605 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) Prescription No No AP 2023/03/07 AMNEAL
211907 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) Prescription No No AP 2024/08/15 HIKMA
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:1GM/200ML (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 010 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 1GM/200ML (5MG/ML) Prescription Yes No AP 2011/01/04 FRESENIUS KABI USA
206166 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 1GM/200ML (5MG/ML) Prescription No No AP 2018/06/11 INFORLIFE
216605 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 1GM/200ML (5MG/ML) Prescription No No AP 2023/03/07 AMNEAL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database