药品注册申请号：078526
申请类型：ANDA (仿制药申请)
申请人：ORBION PHARMS
申请人全名：ORBION PHARMACEUTICALS PRIVATE LTD
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 LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG No No AB 2009/01/15 2009/01/15 Prescription
002 LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG No No AB 2009/01/15 Prescription
003 LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG No No AB 2009/01/15 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
2014/12/09 SUPPL-10（补充） Approval Labeling STANDARD
2014/12/09 SUPPL-9（补充） Approval Labeling STANDARD
2014/12/09 SUPPL-7（补充） Approval Labeling
2012/01/12 SUPPL-6（补充） Approval REMS
2011/09/27 SUPPL-5（补充） Approval Labeling
2010/10/27 SUPPL-4（补充） Approval Labeling
2010/10/27 SUPPL-3（补充） Approval Labeling
2009/08/20 SUPPL-1（补充） Approval Labeling
2009/01/15 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
无
与本品治疗等效的药品
活性成分:LEVETIRACETAM 剂型/给药途径:TABLET;ORAL 规格:250MG 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
205102 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG None (Tentative Approval) No No AB -- SECAN PHARMS
021035 001 NDA KEPPRA LEVETIRACETAM TABLET;ORAL 250MG Prescription Yes No AB 1999/11/30 UCB INC
076919 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Discontinued No No AB 2008/11/04 MYLAN
076920 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 DR REDDYS LABS LTD
078154 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 LUPIN
078234 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Discontinued No No AB 2009/01/15 INVAGEN PHARMS
078526 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 ORBION PHARMS
078858 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 TORRENT PHARMS
078042 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 STRIDES PHARMA
078993 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 AUROBINDO PHARMA
079042 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/01/15 INGENUS PHARMS LLC
078106 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/02/10 PRINSTON INC
078869 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/03/13 VIWIT PHARM
077319 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/03/20 OXFORD PHARMS
078918 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2009/04/29 ZYDUS PHARMS USA INC
078960 004 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2010/02/01 TARO
090767 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2010/07/28 RISING
090515 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2010/10/08 HETERO LABS LTD III
091491 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2010/12/14 ZHEJIANG JINGXIN
090843 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Discontinued No No AB 2011/02/14 ACCORD HLTHCARE
201293 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2011/06/14 CHARTWELL RX
215069 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2022/05/27 SCIEGEN PHARMS INC
216375 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2022/05/27 ALKEM LABS LTD
214815 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Prescription No No AB 2022/10/07 MSN
217878 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 250MG Discontinued No No AB 2023/06/13 GRANULES
活性成分:LEVETIRACETAM 剂型/给药途径:TABLET;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
021035 002 NDA KEPPRA LEVETIRACETAM TABLET;ORAL 500MG Prescription Yes No AB 1999/11/30 UCB INC
076919 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2008/11/04 MYLAN
076920 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 DR REDDYS LABS LTD
078154 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 LUPIN
078234 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Discontinued No No AB 2009/01/15 INVAGEN PHARMS
078526 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 ORBION PHARMS
078858 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 TORRENT PHARMS
078042 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 STRIDES PHARMA
078993 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 AUROBINDO PHARMA
079042 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/01/15 INGENUS PHARMS LLC
078106 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/02/10 PRINSTON INC
078869 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/03/13 VIWIT PHARM
077319 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2009/03/20 OXFORD PHARMS
078960 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2010/02/01 TARO
090767 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2010/07/28 RISING
090515 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2010/10/08 HETERO LABS LTD III
091491 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2010/12/14 ZHEJIANG JINGXIN
090843 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Discontinued No No AB 2011/02/14 ACCORD HLTHCARE
201293 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2011/06/14 CHARTWELL RX
215069 004 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2022/05/27 SCIEGEN PHARMS INC
216375 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2022/05/27 ALKEM LABS LTD
214815 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Prescription No No AB 2022/10/07 MSN
217878 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 500MG Discontinued No No AB 2023/06/13 GRANULES
活性成分:LEVETIRACETAM 剂型/给药途径:TABLET;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
205102 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG None (Tentative Approval) No No AB -- SECAN PHARMS
021035 003 NDA KEPPRA LEVETIRACETAM TABLET;ORAL 750MG Prescription Yes No AB 1999/11/30 UCB INC
076919 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2008/11/04 MYLAN
076920 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 DR REDDYS LABS LTD
078154 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 LUPIN
078234 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Discontinued No No AB 2009/01/15 INVAGEN PHARMS
078526 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 ORBION PHARMS
078858 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 TORRENT PHARMS
078042 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 STRIDES PHARMA
078993 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 AUROBINDO PHARMA
079042 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/01/15 INGENUS PHARMS LLC
078106 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/02/10 PRINSTON INC
078869 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/03/13 VIWIT PHARM
077319 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2009/03/20 OXFORD PHARMS
078960 002 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2010/02/01 TARO
090767 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2010/07/28 RISING
090515 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2010/10/08 HETERO LABS LTD III
091491 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2010/12/14 ZHEJIANG JINGXIN
090843 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Discontinued No No AB 2011/02/14 ACCORD HLTHCARE
201293 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2011/06/14 CHARTWELL RX
215069 001 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2021/06/11 SCIEGEN PHARMS INC
216375 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2022/05/27 ALKEM LABS LTD
214815 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Prescription No No AB 2022/10/07 MSN
217878 003 ANDA LEVETIRACETAM LEVETIRACETAM TABLET;ORAL 750MG Discontinued No No AB 2023/06/13 GRANULES
更多信息
药品NDC数据与药品包装、标签说明书
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