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 |
|---|
| 2023/04/19 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/11/12 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/05/17 |
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 | RLD | RS | TE 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
|
ASTRAZENECA |
| 090482 |
001 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG BASE |
Discontinued |
No |
No |
AB |
2017/05/09
|
ENDO OPERATIONS |
| 202939 |
001 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2017/05/09
|
INTELLIPHARMACEUTICS |
| 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
|
GRAVITI PHARMS |
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 | RLD | RS | TE 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
|
ASTRAZENECA |
| 090482 |
002 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
2017/05/09
|
ENDO OPERATIONS |
| 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
|
INTELLIPHARMACEUTICS |
| 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
|
GRAVITI PHARMS |
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 | RLD | RS | TE 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
|
ASTRAZENECA |
| 090482 |
003 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 200MG BASE |
Discontinued |
No |
No |
AB |
2017/05/09
|
ENDO OPERATIONS |
| 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
|
INTELLIPHARMACEUTICS |
| 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
|
GRAVITI PHARMS |
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 | RLD | RS | TE 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
|
ASTRAZENECA |
| 090482 |
004 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 300MG BASE |
Discontinued |
No |
No |
AB |
2017/05/09
|
ENDO OPERATIONS |
| 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
|
INTELLIPHARMACEUTICS |
| 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
|
GRAVITI PHARMS |
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 | RLD | RS | TE 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
|
ASTRAZENECA |
| 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
|
INTELLIPHARMACEUTICS |
| 090482 |
005 |
ANDA |
QUETIAPINE FUMARATE |
QUETIAPINE FUMARATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 400MG BASE |
Discontinued |
No |
No |
AB |
2017/05/09
|
ENDO OPERATIONS |
| 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
|
GRAVITI PHARMS |