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 |
|---|
| 2023/10/26 |
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: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 |
| 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 | 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 |
| 211907 |
002 |
ANDA |
ROPIVACAINE HYDROCHLORIDE |
ROPIVACAINE HYDROCHLORIDE |
SOLUTION;INJECTION |
400MG/200ML (2MG/ML) |
Prescription |
No |
No |
AP |
2024/08/15
|
HIKMA |