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 |
|---|
| 2018/11/02 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/04/09 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/06/20 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2017/06/20 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2017/06/20 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/08/07 |
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 剂型/给药途径:OINTMENT;TOPICAL 规格:5% 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 |
|---|
| 080198 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
FOUGERA PHARMS INC |
| 086724 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
TARO |
| 040911 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2011/05/23
|
SEPTODONT INC |
| 206297 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2015/08/07
|
AMNEAL PHARMS |
| 205318 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Discontinued |
No |
No |
AT |
2016/02/01
|
ENCUBE |
| 206498 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2016/09/09
|
GLENMARK PHARMS LTD |
| 207810 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2017/03/10
|
ALKEM LABS LTD |
| 211469 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2018/11/23
|
ALEMBIC |
| 210958 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2018/12/11
|
STRIDES PHARMA |
| 211019 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Discontinued |
No |
No |
AT |
2018/12/12
|
COSETTE |
| 211697 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2020/03/16
|
MACLEODS PHARMS LTD |
| 208660 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2021/01/05
|
DR REDDYS |
| 212695 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2021/04/20
|
QUAGEN |
| 217117 |
001 |
ANDA |
LIDOCAINE |
LIDOCAINE |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AT |
2024/06/18
|
AUROBINDO PHARMA LTD |
