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 |
2021/11/09 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/02/10 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/02/10 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/19 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/19 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/19 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/04/24 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/01/18 |
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: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 |
022115 |
001 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
2009/05/29
|
GLAXOSMITHKLINE LLC |
201374 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
202498 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/01/04
|
WOCKHARDT BIO AG |
201791 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
202383 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/06/19
|
DR REDDYS LABS LTD |
200672 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/10/17
|
ACTAVIS ELIZABETH |
203370 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2013/12/23
|
TORRENT |
207497 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
207763 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
213949 |
001 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
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: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 |
022115 |
002 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
2009/05/29
|
GLAXOSMITHKLINE LLC |
201374 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
202498 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/01/04
|
WOCKHARDT BIO AG |
201791 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
202383 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/06/19
|
DR REDDYS LABS LTD |
200672 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/10/17
|
ACTAVIS ELIZABETH |
203370 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/12/23
|
TORRENT |
207497 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
207763 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
213949 |
002 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
50MG |
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: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 |
活性成分:LAMOTRIGINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:250MG 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 |
006 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
Yes |
No |
AB |
2011/06/21
|
GLAXOSMITHKLINE LLC |
201374 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
201791 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
200672 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2013/11/13
|
ACTAVIS ELIZABETH |
202383 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/09/06
|
DR REDDYS LABS LTD |
207497 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
207763 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
213949 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
250MG |
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:300MG 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 |
005 |
NDA |
LAMICTAL XR |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
Yes |
No |
AB |
2010/04/14
|
GLAXOSMITHKLINE LLC |
201374 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2012/12/26
|
ENDO OPERATIONS |
202498 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/01/04
|
WOCKHARDT BIO AG |
201791 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/01/18
|
ENDO OPERATIONS |
202383 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/06/19
|
DR REDDYS LABS LTD |
200672 |
005 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/10/17
|
ACTAVIS ELIZABETH |
207497 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2018/11/30
|
AMNEAL PHARMS |
207763 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2020/04/01
|
ZYDUS PHARMS |
213949 |
006 |
ANDA |
LAMOTRIGINE |
LAMOTRIGINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB |
2021/12/08
|
YILING |