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 |
2020/02/28 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/08 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/08 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/13 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/01/24 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
2010/02/23 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
2009/03/31 |
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:CARBAMAZEPINE 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 |
020234 |
001 |
NDA |
TEGRETOL-XR |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
1996/03/25
|
NOVARTIS |
078115 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2009/03/31
|
TARO |
205571 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ZYDUS PHARMS |
211623 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/04/24
|
UNIQUE PHARM |
213311 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/04/13
|
CSPC OUYI |
212948 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/09/30
|
ANBISON LAB |
215591 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/03/31
|
ZHEJIANG JIUZHOU |
216594 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/08/18
|
UMEDICA |
216404 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/12/02
|
RICONPHARMA LLC |
216235 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/03/02
|
SCIECURE PHARMA INC |
212704 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2023/09/22
|
AMNEAL PHARMS |
213159 |
001 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2024/03/08
|
APOTEX |
活性成分:CARBAMAZEPINE 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 |
020234 |
002 |
NDA |
TEGRETOL-XR |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
1996/03/25
|
NOVARTIS |
078115 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2009/03/31
|
TARO |
205571 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ZYDUS PHARMS |
211623 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/04/24
|
UNIQUE PHARM |
213311 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/04/13
|
CSPC OUYI |
212948 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/09/30
|
ANBISON LAB |
215591 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/03/31
|
ZHEJIANG JIUZHOU |
216594 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/08/18
|
UMEDICA |
216404 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/12/02
|
RICONPHARMA LLC |
216235 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/03/02
|
SCIECURE PHARMA INC |
212704 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2023/09/22
|
AMNEAL PHARMS |
213159 |
002 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2024/03/08
|
APOTEX |
活性成分:CARBAMAZEPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:400MG 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 |
020234 |
003 |
NDA |
TEGRETOL-XR |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
Yes |
Yes |
AB |
1996/03/25
|
NOVARTIS |
078115 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2009/03/31
|
TARO |
205571 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ZYDUS PHARMS |
211623 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2020/04/24
|
UNIQUE PHARM |
213311 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2021/04/13
|
CSPC OUYI |
212948 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2021/09/30
|
ANBISON LAB |
215591 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2022/03/31
|
ZHEJIANG JIUZHOU |
216594 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2022/08/18
|
UMEDICA |
216404 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2022/12/02
|
RICONPHARMA LLC |
216235 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/03/02
|
SCIECURE PHARMA INC |
212704 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2023/09/22
|
AMNEAL PHARMS |
213159 |
003 |
ANDA |
CARBAMAZEPINE |
CARBAMAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2024/03/08
|
APOTEX |