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 |
2011/10/18 |
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:0.5% 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 |
005 |
NDA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
016964 |
006 |
NDA |
MARCAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
018304 |
002 |
NDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
070584 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
1986/02/17
|
HOSPIRA |
070553 |
001 |
ANDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
1986/05/21
|
FRESENIUS KABI USA |
070597 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
1987/03/03
|
HOSPIRA |
070609 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
1987/03/03
|
HOSPIRA |
091487 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2011/10/18
|
STERISCIENCE |
091503 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2011/10/18
|
STERISCIENCE |
203895 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2013/11/05
|
EUGIA PHARMA |
207183 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2016/05/13
|
EUGIA PHARMA |
204842 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2021/02/11
|
HIKMA PHARMS |
205141 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2021/02/11
|
HIKMA PHARMS |
216039 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2023/06/23
|
KINDOS |
217792 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2023/11/20
|
SOMERSET |
216040 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5% |
Prescription |
No |
No |
AP |
2023/12/27
|
KINDOS |
活性成分:BUPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.25% 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 |
001 |
NDA |
MARCAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
016964 |
012 |
NDA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
018304 |
001 |
NDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
070552 |
001 |
ANDA |
SENSORCAINE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
1986/05/21
|
FRESENIUS KABI USA |
070583 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
1987/02/17
|
HOSPIRA |
070590 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
1987/02/17
|
HOSPIRA |
091487 |
002 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2011/10/18
|
STERISCIENCE |
091503 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2011/10/18
|
STERISCIENCE |
203895 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2013/11/05
|
EUGIA PHARMA |
207183 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2016/05/13
|
EUGIA PHARMA |
204842 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2021/02/11
|
HIKMA PHARMS |
205141 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2021/02/11
|
HIKMA PHARMS |
216039 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2023/06/23
|
KINDOS |
217792 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2023/11/20
|
SOMERSET |
216040 |
001 |
ANDA |
BUPIVACAINE HYDROCHLORIDE |
BUPIVACAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.25% |
Prescription |
No |
No |
AP |
2023/12/27
|
KINDOS |
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 |