药品注册申请号：204203
申请类型：ANDA (仿制药申请)
申请人：LUPIN LTD
申请人全名：LUPIN 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 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE No No AB 2017/05/17 2017/05/17 Prescription
002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE No No AB 2017/05/17 Prescription
003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE No No AB 2017/05/17 Prescription
004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE No No AB 2017/05/17 Prescription
005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE No No AB 2017/05/17 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
2017/05/17 ORIG-1（原始申请） Approval
>>>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
2023/04/19 SUPPL-14（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2021/11/12 SUPPL-13（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/11/12 SUPPL-11（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/11/12 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2021/11/12 SUPPL-7（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2021/11/12 SUPPL-6（补充） Approval Labeling-Medication Guide,Labeling-Container/Carton Labels STANDARD
2021/11/12 SUPPL-4（补充） Approval Labeling-Medication Guide,Labeling-Package Insert 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
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, EXTENDED RELEASE;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
022047 001 NDA SEROQUEL XR QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription Yes No AB 2007/05/17 CHEPLAPHARM
090482 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Discontinued No No AB 2017/05/09 PH HEALTH
202939 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/05/09 MEDICAP LABS
206260 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Discontinued No No AB 2017/05/09 PHARMADAX INC
204203 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/05/17 LUPIN LTD
206252 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/11/29 ACCORD HLTHCARE
207655 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/11/29 AUROBINDO PHARMA
208947 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2017/11/29 NOVAST LABS
209635 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2018/11/16 SCIEGEN PHARMS INC
208781 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2022/04/26 PRINSTON INC
215478 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2022/08/15 UNICHEM
211144 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Prescription No No AB 2024/11/26 RISING
>>>活性成分:QUETIAPINE FUMARATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 150MG 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
022047 005 NDA SEROQUEL XR QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription Yes No AB 2008/08/11 CHEPLAPHARM
090482 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2017/05/09 PH HEALTH
090681 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/05/09 ACCORD HLTHCARE
202939 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/05/09 MEDICAP LABS
206260 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Discontinued No No AB 2017/05/09 PHARMADAX INC
204203 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/05/17 LUPIN LTD
204253 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/11/29 MACLEODS PHARMS LTD
207655 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/11/29 AUROBINDO PHARMA
208947 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/11/29 NOVAST LABS
209635 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2017/11/29 SCIEGEN PHARMS INC
209497 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2018/09/28 ALIGNSCIENCE PHARMA
208781 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2022/04/26 PRINSTON INC
215478 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2022/08/15 UNICHEM
211144 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 150MG BASE Prescription No No AB 2024/11/26 RISING
>>>活性成分:QUETIAPINE FUMARATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022047 002 NDA SEROQUEL XR QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription Yes Yes AB 2007/05/17 CHEPLAPHARM
090482 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Discontinued No No AB 2017/05/09 PH HEALTH
090681 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/05/09 ACCORD HLTHCARE
202939 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/05/09 MEDICAP LABS
206260 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Discontinued No No AB 2017/05/09 PHARMADAX INC
204203 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/05/17 LUPIN LTD
204253 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/11/29 MACLEODS PHARMS LTD
207655 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/11/29 AUROBINDO PHARMA
208947 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/11/29 NOVAST LABS
209635 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2017/11/29 SCIEGEN PHARMS INC
209497 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2018/09/28 ALIGNSCIENCE PHARMA
208781 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2022/04/26 PRINSTON INC
215478 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2022/08/15 UNICHEM
211144 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2024/11/26 RISING
>>>活性成分:QUETIAPINE FUMARATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022047 003 NDA SEROQUEL XR QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription Yes No AB 2007/05/17 CHEPLAPHARM
090482 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Discontinued No No AB 2017/05/09 PH HEALTH
090681 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/05/09 ACCORD HLTHCARE
202939 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/05/09 MEDICAP LABS
206260 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Discontinued No No AB 2017/05/09 PHARMADAX INC
204203 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/05/17 LUPIN LTD
204253 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/11/29 MACLEODS PHARMS LTD
207655 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/11/29 AUROBINDO PHARMA
208947 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/11/29 NOVAST LABS
209635 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2017/11/29 SCIEGEN PHARMS INC
208781 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2022/04/26 PRINSTON INC
215478 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2022/08/15 UNICHEM
211144 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 300MG BASE Prescription No No AB 2024/11/26 RISING
>>>活性成分:QUETIAPINE FUMARATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;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
022047 004 NDA SEROQUEL XR QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription Yes No AB 2007/05/17 CHEPLAPHARM
090681 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2016/11/01 ACCORD HLTHCARE
202939 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/05/09 MEDICAP LABS
090482 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Discontinued No No AB 2017/05/09 PH HEALTH
206260 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Discontinued No No AB 2017/05/09 PHARMADAX INC
204203 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/05/17 LUPIN LTD
204253 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/11/29 MACLEODS PHARMS LTD
207655 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/11/29 AUROBINDO PHARMA
208947 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/11/29 NOVAST LABS
209635 004 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2017/11/29 SCIEGEN PHARMS INC
215478 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2022/08/15 UNICHEM
208781 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2024/03/11 PRINSTON INC
211144 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL EQ 400MG BASE Prescription No No AB 2024/11/26 RISING
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database