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 |
|---|
| 2014/07/17 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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: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 |