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 |
|---|
| 2020/01/29 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/29 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/29 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/07/15 |
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, ORALLY DISINTEGRATING;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 |
|---|
| 022251 |
001 |
NDA |
LAMICTAL ODT |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
2009/05/08
|
GLAXOSMITHKLINE LLC |
| 200828 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/07/15
|
IMPAX LABS INC |
| 204158 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
No |
No |
AB |
2015/10/27
|
ENDO OPERATIONS |
| 206382 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/06/17
|
SCIEGEN PHARMS INC |
| 213271 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/01/19
|
AJANTA PHARMA LTD |
| 214124 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/02/03
|
AMRING PHARMS |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:50MG 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 |
|---|
| 022251 |
002 |
NDA |
LAMICTAL ODT |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
2009/05/08
|
GLAXOSMITHKLINE LLC |
| 200828 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/07/15
|
IMPAX LABS INC |
| 204158 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
No |
No |
AB |
2015/10/27
|
ENDO OPERATIONS |
| 206382 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
No |
No |
AB |
2016/06/17
|
SCIEGEN PHARMS INC |
| 213271 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/01/19
|
AJANTA PHARMA LTD |
| 214124 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/02/03
|
AMRING PHARMS |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:100MG 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 |
|---|
| 022251 |
003 |
NDA |
LAMICTAL ODT |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
2009/05/08
|
GLAXOSMITHKLINE LLC |
| 200828 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/07/15
|
IMPAX LABS INC |
| 204158 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
No |
No |
AB |
2015/10/27
|
ENDO OPERATIONS |
| 206382 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/06/17
|
SCIEGEN PHARMS INC |
| 213271 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/01/19
|
AJANTA PHARMA LTD |
| 214124 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/02/03
|
AMRING PHARMS |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:200MG 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 |
|---|
| 022251 |
004 |
NDA |
LAMICTAL ODT |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
2009/05/08
|
GLAXOSMITHKLINE LLC |
| 200828 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/07/15
|
IMPAX LABS INC |
| 204158 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
No |
No |
AB |
2015/10/27
|
ENDO OPERATIONS |
| 206382 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/06/17
|
SCIEGEN PHARMS INC |
| 213271 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/01/19
|
AJANTA PHARMA LTD |
| 214124 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/02/03
|
AMRING PHARMS |
