药品注册申请号：020533
申请类型：NDA (新药申请)
申请人：FRESENIUS KABI USA
申请人全名：FRESENIUS KABI USA LLC
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 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 20MG/10ML (2MG/ML) Yes No AP 1996/09/24 1998/05/01 Prescription
002 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) Yes No AP 1996/09/24 Prescription
003 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) Yes No AP 1998/05/01 Prescription
004 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) Yes No AP 1996/09/24 Prescription
005 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) Yes No AP 1996/09/24 Prescription
006 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/100ML (2MG/ML) Yes No AP 1996/09/24 Prescription
007 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 400MG/200ML (2MG/ML) Yes No AP 1996/09/24 Prescription
008 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) Yes No AP 1996/09/24 Prescription
009 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 500MG/100ML (5MG/ML) Yes No AP 2011/01/04 Prescription
010 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 1GM/200ML (5MG/ML) Yes No AP 2011/01/04 Prescription
011 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) Yes Yes AP 1996/09/24 Prescription
012 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1996/09/24 Discontinued
013 NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1998/05/01 Discontinued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
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
2022/06/28 SUPPL-44（补充） Approval Labeling STANDARD
2022/06/15 SUPPL-38（补充） Approval Labeling STANDARD
2018/11/02 SUPPL-35（补充） Approval Labeling STANDARD
2018/02/15 SUPPL-34（补充） Approval STANDARD
2016/06/06 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
2014/10/29 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2013/04/21 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
2013/02/16 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2012/12/26 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2012/11/15 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2012/11/09 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2010/02/19 SUPPL-21（补充） Approval Labeling STANDARD
2010/02/19 SUPPL-20（补充） Approval Labeling 901 REQUIRED
2006/08/08 SUPPL-14（补充） Approval Labeling STANDARD
2004/08/11 SUPPL-12（补充） Approval Labeling STANDARD
2002/07/17 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
2000/11/14 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2000/11/02 SUPPL-2（补充） Approval Efficacy STANDARD
2000/06/22 SUPPL-5（补充） Approval Labeling STANDARD
2000/02/09 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1998/05/01 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1996/09/24 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
006 7828787 2025/10/18 Y 2014/11/06 PDF格式
7857802 2026/11/28 Y 2014/11/06 PDF格式
8162915 2024/05/23 Y 2014/11/06 PDF格式
007 7828787 2025/10/18 Y 2014/11/06 PDF格式
7857802 2026/11/28 Y 2014/11/06 PDF格式
8162915 2024/05/23 Y 2014/11/06 PDF格式
001 4870086 2010/09/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/05/26 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/09/23 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5834489 2014/05/26 Y Y U-838 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4870086 2010/09/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/05/26 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/09/23 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5834489 2014/05/26 Y Y U-838 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4870086 2010/09/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/05/26 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/09/23 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5834489 2014/05/26 Y Y U-838 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4870086 2010/09/24 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/05/26 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5670524 2014/09/23 Y Y U-833 PDF格式**本条是由Drugfuture回溯的历史信息**
5834489 2014/05/26 Y Y U-838 PDF格式**本条是由Drugfuture回溯的历史信息**
006 8118802 2023/05/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
007 8118802 2023/05/18 Y 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:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:20MG/10ML (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 001 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 20MG/10ML (2MG/ML) Prescription Yes No AP 1998/05/01 FRESENIUS KABI USA
090194 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 20MG/10ML (2MG/ML) Prescription No No AP 2014/09/23 HOSPIRA
207636 001 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 20MG/10ML (2MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
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) Prescription 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
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:100MG/20ML (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 003 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) Prescription Yes No AP 1998/05/01 FRESENIUS KABI USA
205612 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 003 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
212808 002 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) Prescription No No AP 2020/04/09 CAPLIN
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) Prescription 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
活性成分:ROPIVACAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:100MG/10ML (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 005 NDA NAROPIN ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) Prescription Yes No AP 1996/09/24 FRESENIUS KABI USA
090194 004 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2014/09/23 HOSPIRA
205612 006 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2016/07/13 EUGIA PHARMA
207636 006 ANDA ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2018/06/15 SOMERSET THERAPS LLC
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
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
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) Prescription 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
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
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
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) Prescription 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
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