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 |
2019/10/29 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/08/03 |
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: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 |
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 |
Yes |
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
|
HIKMA |
006488 |
007 |
NDA |
XYLOCAINE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
088586 |
002 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1% |
Prescription |
No |
No |
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 |