药品注册申请号:021505
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 LEVETIRACETAM SOLUTION;ORAL 100MG/ML Yes Yes AA 2003/07/15 2003/07/15 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
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
2024/03/12 SUPPL-53(补充) Approval Labeling STANDARD
2023/08/31 SUPPL-52(补充) Approval Labeling STANDARD
2023/08/17 SUPPL-51(补充) Approval Labeling STANDARD
2020/09/30 SUPPL-44(补充) Approval Labeling STANDARD
2019/10/23 SUPPL-42(补充) Approval Efficacy STANDARD
2017/10/24 SUPPL-40(补充) Approval Labeling STANDARD
2017/04/24 SUPPL-38(补充) Approval Labeling STANDARD
2016/10/26 SUPPL-36(补充) Approval Labeling STANDARD
2015/03/10 SUPPL-33(补充) Approval Labeling STANDARD
2014/08/07 SUPPL-34(补充) Approval Labeling STANDARD
2014/03/07 SUPPL-31(补充) Approval Labeling STANDARD
2013/09/13 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
2013/07/25 SUPPL-30(补充) Approval Labeling UNKNOWN
2011/12/16 SUPPL-26(补充) Approval Labeling STANDARD
2011/12/16 SUPPL-25(补充) Approval Labeling STANDARD
2011/12/16 SUPPL-20(补充) Approval Labeling STANDARD
2011/12/16 SUPPL-19(补充) Approval Efficacy PRIORITY
2011/08/10 SUPPL-29(补充) Approval REMS N/A
2009/04/23 SUPPL-24(补充) Approval Labeling STANDARD
2009/04/23 SUPPL-22(补充) Approval Labeling STANDARD
2009/04/23 SUPPL-21(补充) Approval Labeling 901 REQUIRED
2007/09/12 SUPPL-15(补充) Approval Labeling STANDARD
2007/03/19 SUPPL-13(补充) Approval Efficacy STANDARD
2006/08/15 SUPPL-9(补充) Approval Efficacy UNKNOWN
2006/01/24 SUPPL-6(补充) Approval Labeling STANDARD
2005/06/21 SUPPL-7(补充) Approval Efficacy PRIORITY
2004/10/26 SUPPL-3(补充) Approval Labeling STANDARD
2004/10/26 SUPPL-2(补充) Approval Labeling STANDARD
2003/07/15 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)
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 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 I-506 2009/08/15**本条是由Drugfuture回溯的历史信息**
I-527 2010/03/19**本条是由Drugfuture回溯的历史信息**
NPP 2008/06/21**本条是由Drugfuture回溯的历史信息**
NPP 2014/12/16**本条是由Drugfuture回溯的历史信息**
PED 2008/12/21**本条是由Drugfuture回溯的历史信息**
PED 2010/02/15**本条是由Drugfuture回溯的历史信息**
PED 2010/09/19**本条是由Drugfuture回溯的历史信息**
PED 2015/06/16**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:SOLUTION;ORAL 规格:100MG/ML 治疗等效代码:AA
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
021505 001 NDA KEPPRA LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription Yes Yes AA 2003/07/15 UCB INC
078582 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/01/15 ACI
078976 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/01/15 ACTAVIS MID ATLANTIC
079063 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/01/15 AUROBINDO PHARMA
079120 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/01/16 BIONPHARMA
078774 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/02/10 TARO
090263 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/04/03 CHARTWELL MOLECULAR
090992 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2009/10/27 AMNEAL PHARMS
090461 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2010/09/30 BELCHER
090893 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2011/10/17 LUPIN LTD
090601 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2012/02/28 HIKMA
090079 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2012/04/11 QUAGEN
203052 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2013/02/28 HETERO LABS LTD III
203067 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2013/05/09 ALEMBIC
201157 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2015/06/04 PHARM ASSOC
214757 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2022/07/15 MSN
214673 001 ANDA LEVETIRACETAM LEVETIRACETAM SOLUTION;ORAL 100MG/ML Prescription No No AA 2023/11/20 STRIDES PHARMA
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