Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | 1 | SEROQUEL XR | QUETIAPINE FUMARATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | 1 | SEROQUEL XR | QUETIAPINE FUMARATE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | 1 | SEROQUEL XR | QUETIAPINE FUMARATE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | 1 | SEROQUEL XR | QUETIAPINE FUMARATE |
| 005 | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | 1 | SEROQUEL XR | QUETIAPINE FUMARATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2007-05-17 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2008-03-13 | N/A |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2008-10-08 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2008-10-08 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2008-10-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2008-05-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2009-12-02 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2008-08-11 | N/A |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-12-02 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2009-12-02 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2008-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2009-12-02 | |
| LABELING; Labeling | SUPPL | 22 | AP | 2009-12-02 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2011-07-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 24 | AP | 2011-05-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 25 | AP | 2010-12-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 26 | AP | 2013-04-30 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2011-07-08 | UNKNOWN |
| REMS; REMS | SUPPL | 28 | AP | 2011-11-09 | N/A |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2013-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2013-04-30 | |
| LABELING; Labeling | SUPPL | 31 | AP | 2013-04-30 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2018-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2013-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2015-01-26 | |
| LABELING; Labeling | SUPPL | 37 | AP | 2018-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2016-06-17 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 39 | AP | 2017-02-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 40 | AP | 2019-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2020-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2020-02-05 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 44 | AP | 2020-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2022-01-27 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 15 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 15 |
| SUPPL | 46 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 22047
[companyName] => ASTRAZENECA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022047s041s044lbl.pdf#page=52"]
[products] => [{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/18\/2020","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022047s041s044lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2020","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022047Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2020","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022047Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2020","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022047s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2019","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022047s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022047s033s037lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022047s033s037lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-39","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022047s039lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022047s039lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022047s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2015","submission":"SUPPL-36","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022047s036lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/29\/2013","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022047s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022047s026s029s030s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022047s026s029s030s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-29","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022047s026s029s030s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2013","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022047s026s029s030s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2011","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022047s023s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2011","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022047s023s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2011","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022047s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022047s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022047s011s016s017s019s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022047s011s016s017s019s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022047s011s016s017s019s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2009","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022047s011s016s017s019s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2009","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022047s011s016s017s019s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2008","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2008","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2008","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022047s002lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"EQ 400MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-09-18
)
)