药品注册申请号：020639
申请类型：NDA (新药申请)
申请人：CHEPLAPHARM
申请人全名：CHEPLAPHARM ARZNEIMITTEL GMBH
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 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Yes Yes AB 1997/09/26 1997/09/26 Prescription
002 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Yes No AB 1997/09/26 Prescription
003 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Yes No AB 1997/09/26 Prescription
004 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1998/12/20 Discontinued
005 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Yes Yes AB 2000/07/26 Prescription
006 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Yes No AB 2005/10/04 Prescription
007 SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Yes No AB 2005/10/04 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
1997/09/26 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
2025/01/22 SUPPL-74（补充） Approval Labeling-Package Insert STANDARD
2022/01/27 SUPPL-72（补充） Approval Labeling-Package Insert STANDARD
2020/09/18 SUPPL-70（补充） Approval Labeling-Package Insert STANDARD
2020/03/27 SUPPL-68（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2020/02/05 SUPPL-69（补充） Approval Labeling-Package Insert 901 REQUIRED
2019/08/26 SUPPL-66（补充） Approval Labeling-Package Insert STANDARD
2018/11/29 SUPPL-63（补充） Approval Labeling-Package Insert STANDARD
2018/11/29 SUPPL-60（补充） Approval Labeling-Package Insert STANDARD
2017/02/23 SUPPL-65（补充） Approval Labeling-Package Insert 901 REQUIRED
2016/06/17 SUPPL-64（补充） Approval Labeling-Package Insert 901 REQUIRED
2013/10/29 SUPPL-61（补充） Approval Labeling-Package Insert STANDARD
2013/04/30 SUPPL-59（补充） Approval Labeling STANDARD
2013/04/30 SUPPL-58（补充） Approval Labeling STANDARD
2013/04/30 SUPPL-57（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2013/04/30 SUPPL-53（补充） Approval Labeling STANDARD
2011/11/09 SUPPL-55（补充） Approval REMS-Modified N/A
2011/07/08 SUPPL-54（补充） Approval Labeling UNKNOWN
2011/07/08 SUPPL-49（补充） Approval Labeling-Package Insert UNKNOWN
2011/05/17 SUPPL-51（补充） Approval Labeling-Package Insert UNKNOWN
2010/12/01 SUPPL-52（补充） Approval Labeling 901 REQUIRED
2009/12/02 SUPPL-46（补充） Approval Efficacy-New Patient Population PRIORITY
2009/12/02 SUPPL-45（补充） Approval Efficacy-New Patient Population PRIORITY
2008/10/24 SUPPL-30（补充） Approval Labeling STANDARD
2008/08/14 SUPPL-43（补充） Approval Labeling STANDARD
2008/05/13 SUPPL-40（补充） Approval Labeling STANDARD
2008/05/13 SUPPL-38（补充） Approval Labeling STANDARD
2008/05/13 SUPPL-37（补充） Approval Efficacy-New Indication STANDARD
2008/05/13 SUPPL-25（补充） Approval Labeling STANDARD
2008/01/28 SUPPL-39（补充） Approval Labeling STANDARD
2008/01/28 SUPPL-31（补充） Approval Labeling STANDARD
2007/07/30 SUPPL-35（补充） Approval Labeling STANDARD
2006/10/20 SUPPL-26（补充） Approval Efficacy-New Indication UNKNOWN
2006/09/20 SUPPL-23（补充） Approval Labeling STANDARD
2006/02/07 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2004/07/21 SUPPL-20（补充） Approval Labeling STANDARD
2004/01/12 SUPPL-17（补充） Approval Efficacy-New Indication STANDARD
2004/01/12 SUPPL-16（补充） Approval Efficacy-New Indication STANDARD
2002/12/06 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2001/11/16 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2001/03/27 SUPPL-11（补充） Approval Labeling STANDARD
2001/03/19 SUPPL-12（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/01/24 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
2000/11/06 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
2000/07/26 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2000/07/07 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1998/12/20 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1998/05/08 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1998/02/23 SUPPL-1（补充） Approval Manufacturing (CMC) 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 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
006 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
007 4879288 2011/09/26 Y Y U-550 PDF格式**本条是由Drugfuture回溯的历史信息**
4879288*PED 2012/03/26 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-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
002 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
003 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
004 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
005 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
006 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**本条是由Drugfuture回溯的历史信息**
007 I-418 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-419 2007/01/12**本条是由Drugfuture回溯的历史信息**
I-503 2009/10/20**本条是由Drugfuture回溯的历史信息**
I-560 2011/05/13**本条是由Drugfuture回溯的历史信息**
PED 2010/04/20**本条是由Drugfuture回溯的历史信息**
PED 2011/11/13**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:QUETIAPINE FUMARATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 25MG 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 001 NDA SEROQUEL QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription Yes Yes AB 1997/09/26 CHEPLAPHARM
077380 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 RISING
077745 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 TEVA PHARMS
090120 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 HIKMA
090960 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 SCIEGEN PHARMS INC
091388 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 AUROBINDO PHARMA LTD
201109 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 LUPIN LTD
201190 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 SUN PHARM
202152 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2012/03/27 ACCORD HLTHCARE
078679 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Discontinued No No AB 2012/12/14 CHARTWELL RX
201504 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2013/02/12 ALKEM LABS LTD
202674 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2016/03/08 UNICHEM
203359 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2016/05/17 MACLEODS PHARMS LTD
204316 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2022/06/16 HETERO LABS LTD V
206954 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2022/08/24 PRINSTON INC
205983 001 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 25MG BASE Discontinued 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 CHEPLAPHARM
077380 003 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2012/03/27 RISING
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 Discontinued 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 CHEPLAPHARM
077380 005 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 200MG BASE Prescription No No AB 2012/03/27 RISING
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 Discontinued 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 Discontinued 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 CHEPLAPHARM
077380 006 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2012/03/27 RISING
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 Discontinued 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 CHEPLAPHARM
077380 007 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 400MG BASE Prescription No No AB 2012/03/27 RISING
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 Discontinued 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 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 CHEPLAPHARM
077380 002 ANDA QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2012/03/27 RISING
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 Discontinued No No AB 2024/05/20 IPCA LABS LTD
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