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 |
2019/01/04 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/22 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/17 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/23 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/17 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/05/06 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/14 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/07/03 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/06/06 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/08 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/08 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/10/30 |
SUPPL-31(补充) |
Approval |
REMS |
N/A
|
|
|
2011/03/03 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/23 |
SUPPL-26(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2007/08/31 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/09 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2005/11/09 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2005/10/28 |
SUPPL-13(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2005/03/25 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/08/07 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2003/03/27 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/05/01 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/01 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/14 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/08/29 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/06/02 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/01/14 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;ORAL 规格:150MG 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 |
021014 |
001 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
Yes |
No |
AB |
2000/01/14
|
NOVARTIS |
077794 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
077802 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
077801 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
078005 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2007/12/11
|
ANI PHARMS |
078069 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
077747 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
215939 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
211747 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
207717 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;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 |
021014 |
002 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
Yes |
No |
AB |
2000/01/14
|
NOVARTIS |
077794 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
077802 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
077801 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
078005 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2007/12/11
|
ANI PHARMS |
078069 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
077747 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
215939 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
211747 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
207717 |
002 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;ORAL 规格:600MG 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 |
021014 |
003 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
Yes |
Yes |
AB |
2000/01/14
|
NOVARTIS |
077794 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/10/09
|
SUN PHARM INDS |
077802 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/10/09
|
GLENMARK PHARMS LTD |
077801 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/11/15
|
TARO |
078005 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2007/12/11
|
ANI PHARMS |
078069 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2008/01/11
|
BRECKENRIDGE PHARM |
077747 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2008/04/09
|
RUBICON |
215939 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2022/01/11
|
ANNORA PHARMA |
211747 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Discontinued |
No |
No |
AB |
2023/07/03
|
ZYDUS |
207717 |
003 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
TABLET;ORAL |
600MG |
Prescription |
No |
No |
AB |
2024/03/05
|
RUBICON |