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 |
|---|
| 2019/12/17 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/12/17 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/12/17 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/29 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/29 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/12/29 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/12 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:LAMOTRIGINE 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL 规格:5MG 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 |
|---|
| 020764 |
001 |
NDA |
LAMICTAL CD |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
1998/08/24
|
GLAXOSMITHKLINE LLC |
| 076701 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/01/22
|
DR REDDYS LABS LTD |
| 076928 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/01/22
|
WATSON LABS |
| 078009 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/01/22
|
ZYDUS PHARMS USA INC |
| 079204 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/02/04
|
TARO |
| 079099 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/02/19
|
GLENMARK PHARMS LTD |
| 090401 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/11/04
|
AUROBINDO PHARMA |
| 201168 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/06/12
|
ALEMBIC |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL 规格:25MG 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 |
|---|
| 020764 |
002 |
NDA |
LAMICTAL CD |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
Yes |
Yes |
AB |
1998/08/24
|
GLAXOSMITHKLINE LLC |
| 076701 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/01/22
|
DR REDDYS LABS LTD |
| 076928 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/01/22
|
WATSON LABS |
| 078009 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/01/22
|
ZYDUS PHARMS USA INC |
| 079204 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/02/04
|
TARO |
| 079099 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/02/19
|
GLENMARK PHARMS LTD |
| 090401 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2009/11/04
|
AUROBINDO PHARMA |
| 201168 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, FOR SUSPENSION;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/06/12
|
ALEMBIC |