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 |
|---|
| 2021/08/20 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/06/30 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2000/03/27 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/03/27 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/08/28 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/06/18 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1991/03/04 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/08/31 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1988/11/01 |
SUPPL-2（补充） |
Approval |
Bioequivalence |
|
|
|
| 1988/10/17 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1988/09/27 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/09/27 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/04/03 |
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:LIDOCAINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;TOPICAL 规格:4% 治疗等效代码:AT
| 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 |
|---|
| 086364 |
001 |
ANDA |
LARYNG-O-JET KIT |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
INTL MEDICATION |
| 087881 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
1982/11/18
|
WOCKHARDT BIO AG |
| 088803 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
Yes |
AT |
1985/04/03
|
HIKMA |
| 040710 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
2007/02/27
|
LANNETT CO INC |
| 204494 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
2014/03/12
|
PAI HOLDINGS PHARM |
| 216250 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
2022/03/23
|
NOVITIUM PHARMA |
| 218182 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
2023/12/07
|
TARO |
| 218411 |
001 |
ANDA |
LIDOCAINE HYDROCHLORIDE |
LIDOCAINE HYDROCHLORIDE |
SOLUTION;TOPICAL |
4% |
Prescription |
No |
No |
AT |
2024/04/29
|
THE J MOLNER |