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 |
|---|
| 2021/07/06 |
SUPPL-41（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/12/09 |
SUPPL-40（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/12/09 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/08/18 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/04/07 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 2005/01/27 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2002/10/25 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/22 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/22 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/01/07 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2000/01/07 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/11/02 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 1996/10/22 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/10/03 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/09/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/09/25 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1990/05/07 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1989/08/23 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1987/03/03 |
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:BUPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.75% 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 |
|---|
| 016964 |
009 |
NDA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 018304 |
003 |
NDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 070554 |
001 |
ANDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
1986/05/21
|
FRESENIUS KABI USA |
| 070585 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
1987/03/03
|
HOSPIRA |
| 091487 |
003 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
2011/10/18
|
STERISCIENCE |
| 203895 |
003 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
2013/11/05
|
EUGIA PHARMA |
| 204842 |
003 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
2021/02/11
|
HIKMA PHARMS |
| 216040 |
003 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
2023/12/27
|
KINDOS |
| 217821 |
003 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.75% |
Prescription |
No |
No |
AP |
2024/03/27
|
ASPIRO |