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 |
|---|
| 2020/03/19 |
SUPPL-41（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/03/19 |
SUPPL-40（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/04/16 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 2002/10/25 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/22 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/22 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/01/07 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 2000/01/07 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/05/05 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/16 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/10/03 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/01/26 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/07/26 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/02/05 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1990/11/20 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/11/20 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/23 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1986/08/15 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/04/16 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/05/17 |
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:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1% 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 |
|---|
| 080404 |
002 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 080407 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
WEST-WARD PHARMS INT |
| 080408 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 083158 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 083173 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
INTL MEDICATION |
| 084625 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
WEST-WARD PHARMS INT |
| 006488 |
007 |
NDA |
XYLOCAINE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 088329 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
1984/05/17
|
HOSPIRA |
| 088299 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
1984/07/31
|
HOSPIRA |
| 088586 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
1985/07/24
|
FRESENIUS KABI USA |
| 040302 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
1998/09/28
|
HOSPIRA |
| 203040 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2013/03/14
|
EUGIA PHARMA |
| 203082 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2013/03/14
|
EUGIA PHARMA |
| 207182 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2017/10/30
|
EUGIA PHARMA |
| 208017 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2018/04/18
|
SPECTRA MDCL DEVICES |
| 208474 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2018/08/03
|
B BRAUN MEDICAL INC |
| 212821 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2020/05/07
|
HUONS |
| 214336 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2021/11/08
|
ASPIRO |
| 214339 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2021/11/08
|
ASPIRO |
| 215132 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2022/06/09
|
AFAXYS |
| 214267 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2022/09/19
|
SINTETICA US |
| 217692 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2023/06/16
|
MANKIND PHARMA |
| 217693 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2023/07/11
|
MANKIND PHARMA |
| 217692 |
003 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
AP |
2023/11/29
|
MANKIND PHARMA |