药品注册申请号：090749
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE No No AB 2012/03/27 2012/03/27 Prescription
002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE No No AB 2012/03/27 Prescription
003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE No No AB 2012/03/27 Prescription
004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE No No AB 2012/03/27 Prescription
005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE No No AB 2012/03/27 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
2023/02/08 SUPPL-15（补充） Approval Labeling STANDARD
2023/02/08 SUPPL-12（补充） Approval Labeling STANDARD
2023/02/08 SUPPL-11（补充） Approval Labeling STANDARD
2023/02/08 SUPPL-10（补充） Approval Labeling STANDARD
2019/12/11 SUPPL-8（补充） Approval Labeling STANDARD
2019/12/11 SUPPL-7（补充） Approval Labeling STANDARD
2017/06/22 SUPPL-6（补充） Approval Labeling STANDARD
2017/06/22 SUPPL-5（补充） Approval Labeling STANDARD
2015/09/04 SUPPL-4（补充） Approval Labeling STANDARD
2015/09/04 SUPPL-2（补充） Approval Labeling STANDARD
2012/03/27 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:QUETIAPINE FUMARATE 剂型/给药途径:TABLET;ORAL 规格:EQ 50MG BASE 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
020639 007 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription Yes No AB 2005/10/04 ASTRAZENECA
077380 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 DR REDDYS LABS LTD
077745 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090749 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2024/05/20 IPCA LABS LTD
活性成分:QUETIAPINE FUMARATE 剂型/给药途径:TABLET;ORAL 规格:EQ 100MG BASE 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
020639 002 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription Yes No AB 1997/09/26 ASTRAZENECA
077380 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 DR REDDYS LABS LTD
077745 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090749 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2024/05/20 IPCA LABS LTD
活性成分:QUETIAPINE FUMARATE 剂型/给药途径:TABLET;ORAL 规格:EQ 200MG BASE 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
020639 003 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription Yes No AB 1997/09/26 ASTRAZENECA
077380 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 DR REDDYS LABS LTD
077745 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090749 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2024/05/20 IPCA LABS LTD
活性成分:QUETIAPINE FUMARATE 剂型/给药途径:TABLET;ORAL 规格:EQ 300MG BASE 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
020639 005 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription Yes Yes AB 2000/07/26 ASTRAZENECA
077380 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 DR REDDYS LABS LTD
077745 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090749 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2024/05/20 IPCA LABS LTD
活性成分:QUETIAPINE FUMARATE 剂型/给药途径:TABLET;ORAL 规格:EQ 400MG BASE 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
020639 006 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription Yes No AB 2005/10/04 ASTRAZENECA
077380 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 DR REDDYS LABS LTD
077745 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090749 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2024/05/20 IPCA LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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