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 |
|---|
| 2021/02/01 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/22 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/22 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/02/24 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/02/24 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/02/24 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/02/24 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/06/17 |
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:LAMOTRIGINE 剂型/给药途径:TABLET, EXTENDED RELEASE;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 |
|---|
| 022115 |
003 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
2009/05/29
|
GLAXOSMITHKLINE LLC |
| 201374 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
| 202498 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/01/04
|
WOCKHARDT BIO AG |
| 201791 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
| 202887 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/06/17
|
RUBICON |
| 202383 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/06/19
|
DR REDDYS LABS LTD |
| 200672 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/10/17
|
ACTAVIS ELIZABETH |
| 203370 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/12/23
|
TORRENT |
| 207497 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
| 207763 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
| 213949 |
003 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/12/08
|
YILING |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, EXTENDED RELEASE;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 |
|---|
| 022115 |
004 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
Yes |
Yes |
AB |
2009/05/29
|
GLAXOSMITHKLINE LLC |
| 201374 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
| 202498 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/01/04
|
WOCKHARDT BIO AG |
| 201791 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
| 202887 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/06/17
|
RUBICON |
| 202383 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/06/19
|
DR REDDYS LABS LTD |
| 200672 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2013/10/17
|
ACTAVIS ELIZABETH |
| 203370 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2013/12/23
|
TORRENT |
| 207497 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
| 207763 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
| 213949 |
004 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/12/08
|
YILING |
| 211821 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2024/10/01
|
ALEMBIC |