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 |
|---|
| 2024/07/15 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/05/01 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/12/03 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/12/28 |
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:CLOBAZAM 剂型/给药途径:SUSPENSION;ORAL 规格:2.5MG/ML 治疗等效代码:AB
| 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 |
|---|
| 203993 |
001 |
NDA |
ONFI |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
Yes |
Yes |
AB |
2012/12/14
|
LUNDBECK PHARMS LLC |
| 208819 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2018/10/22
|
BIONPHARMA |
| 209715 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Discontinued |
No |
No |
AB |
2018/10/22
|
HIKMA |
| 210039 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2018/10/22
|
AMNEAL |
| 210569 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Discontinued |
No |
No |
AB |
2018/10/22
|
UPSHER SMITH LABS |
| 211259 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Discontinued |
No |
No |
AB |
2018/10/22
|
NORVIUM BIOSCIENCE |
| 210546 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2018/12/28
|
LUPIN LTD |
| 210978 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2019/04/15
|
TARO |
| 210746 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Discontinued |
No |
No |
AB |
2019/07/10
|
VISTAPHARM |
| 209796 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2020/02/24
|
HETERO LABS LTD III |
| 213110 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2020/04/24
|
CHARTWELL MOLECULAR |
| 213039 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2021/05/06
|
ALKEM LABS LTD |
| 214404 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Prescription |
No |
No |
AB |
2022/03/24
|
AUROBINDO PHARMA LTD |
| 216008 |
001 |
ANDA |
CLOBAZAM |
CLOBAZAM |
SUSPENSION;ORAL |
2.5MG/ML |
Discontinued |
No |
No |
AB |
2022/09/06
|
ACCORD HLTHCARE |