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 |
2024/09/04 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/04 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/22 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/17 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/23 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/07/03 |
SUPPL-27(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2014/06/06 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/08 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/02/28 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/08 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/10/30 |
SUPPL-25(补充) |
Approval |
REMS |
N/A
|
|
|
2011/03/03 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/03 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/23 |
SUPPL-21(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2007/08/31 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/10/28 |
SUPPL-8(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2005/03/25 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/09/10 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/01 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/01/18 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/05/25 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
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:SUSPENSION;ORAL 规格:300MG/5ML 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 |
021285 |
001 |
NDA |
TRILEPTAL |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
Yes |
Yes |
AB |
2001/05/25
|
NOVARTIS |
078734 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2009/06/26
|
SUN PHARM INDS LTD |
202961 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2012/09/17
|
AMNEAL PHARMS |
201193 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Discontinued |
No |
No |
AB |
2012/10/03
|
HIKMA |
212428 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2021/06/21
|
CHARTWELL RX |
211420 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Discontinued |
No |
No |
AB |
2021/07/09
|
RENEW PHARMS |
215726 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/08/30
|
RUBICON |
209652 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/11/04
|
BIONPHARMA |
215332 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2022/11/30
|
AUCTA |
213183 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2023/03/18
|
ALKEM LABS LTD |
216749 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2023/10/20
|
HETERO LABS LTD III |
217782 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2024/02/14
|
MEDLEY PHARMS |
218278 |
001 |
ANDA |
OXCARBAZEPINE |
OXCARBAZEPINE |
SUSPENSION;ORAL |
300MG/5ML |
Prescription |
No |
No |
AB |
2024/03/01
|
BIOCON PHARMA |