药品注册申请号：022285
申请类型：NDA (新药申请)
申请人：UCB INC
申请人全名：UCB INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Yes No AB 2008/09/12 2008/09/12 Prescription
002 KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Yes Yes AB 2009/02/12 Prescription
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2008/09/12 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/03/12 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2023/08/17 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2020/09/30 SUPPL-29（补充） Approval Labeling-Package Insert STANDARD
2019/10/23 SUPPL-28（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2017/10/24 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD
2017/04/24 SUPPL-25（补充） Approval Labeling-Package Insert STANDARD
2016/10/26 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2016/04/06 SUPPL-22（补充） Approval Labeling-Medication Guide STANDARD
2015/03/10 SUPPL-17（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert,Labeling-Medication Guide STANDARD
2014/08/07 SUPPL-20（补充） Approval Labeling-Package Insert STANDARD
2014/08/01 SUPPL-18（补充） Approval Efficacy-Pediatric STANDARD
2014/03/07 SUPPL-19（补充） Approval Labeling-Container/Carton Labels STANDARD
2014/03/07 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2013/07/25 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2013/07/25 SUPPL-13（补充） Approval Labeling-Package Insert UNKNOWN
2011/08/10 SUPPL-14（补充） Approval REMS-Modified N/A
2009/04/23 SUPPL-7（补充） Approval Labeling,REMS-Proposal STANDARD
2009/04/23 SUPPL-3（补充） Approval Labeling STANDARD
2009/04/23 SUPPL-2（补充） Approval Labeling 901 REQUIRED
2009/02/12 SUPPL-1（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
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
001 7858122 2028/09/17 Y 2011/01/07 PDF格式
002 7858122 2028/09/17 Y PDF格式
001 4943639 2008/07/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
4943639*PED 2009/01/14 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 NDF 2011/09/12**本条是由Drugfuture回溯的历史信息**
002 NDF 2011/09/12**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:LEVETIRACETAM; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:500MG; 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RLDRSTE Code产品号批准日期申请人
022285 001 NDA KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription Yes No AB 2008/09/12 UCB INC
091093 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2011/09/12 ACTAVIS LABS FL INC
091261 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2011/09/12 APOTEX INC
091399 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2011/09/12 LUPIN LTD
091360 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2011/10/04 PH HEALTH
201464 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2012/05/25 PHARMADAX INC
091338 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2012/05/29 TORRENT PHARMS LTD
202533 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2012/07/20 PRINSTON INC
203059 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2013/09/09 SUN PHARM
203468 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2015/05/21 PRINSTON INC
202167 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2015/09/04 ADAPTIS
204511 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2016/02/23 ANDA REPOSITORY
204754 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2016/08/26 AIPING PHARM INC
207175 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2017/09/28 HISUN PHARM HANGZHOU
205130 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/11/27 SCIEGEN PHARMS INC
212688 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2023/05/05 OVERSEAS
>>>活性成分:LEVETIRACETAM; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:750MG; 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RLDRSTE Code产品号批准日期申请人
022285 002 NDA KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription Yes Yes AB 2009/02/12 UCB INC
091093 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2011/09/12 ACTAVIS LABS FL INC
091261 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2011/09/12 APOTEX INC
091399 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2011/09/12 LUPIN LTD
091360 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2011/10/04 PH HEALTH
201464 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2012/05/25 PHARMADAX INC
091338 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2012/05/29 TORRENT PHARMS LTD
202533 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2012/07/20 PRINSTON INC
203059 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2013/09/09 SUN PHARM
203468 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2015/05/21 PRINSTON INC
202167 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2015/09/04 ADAPTIS
204511 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2016/02/23 ANDA REPOSITORY
204754 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2016/08/26 AIPING PHARM INC
207175 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2017/09/28 HISUN PHARM HANGZHOU
212688 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2020/06/11 OVERSEAS
205130 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2020/11/27 SCIEGEN PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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