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 |
2023/05/11 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/11 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/10/06 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/29 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/02/12 |
ORIG-1(原始申请) |
Approval |
Not Applicable |
|
|
|
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 | RLD | RS | TE 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
|
ASTRAZENECA |
077380 |
001 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2012/03/27
|
DR REDDYS LABS LTD |
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 |
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 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 | RLD | RS | TE 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 | RLD | RS | TE 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 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
077380 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2012/03/27
|
DR REDDYS LABS LTD |
077745 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2012/03/27
|
TEVA PHARMS |
091388 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2012/03/27
|
AUROBINDO PHARMA LTD |
078679 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
2012/12/14
|
CHARTWELL RX |
201504 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2013/02/12
|
ALKEM 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 | RLD | RS | TE 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 | RLD | RS | TE 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 | RLD | RS | TE 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 |