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 |
2024/01/02 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/12/21 |
SUPPL-7(补充) |
Tentative Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2020/04/09 |
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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 |
218713 |
003 |
ANDA |
ROPIVACAINE HYDROCHLORIDE |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
100MG/20ML (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/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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 |
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 | RLD | RS | TE 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 |
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 | RLD | RS | TE 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 |