NDA 022172

ASTRAZENECA

FDA Drug Application

Application #022172

Documents

• Letter: 2007-11-19
• Label: 2007-11-19
• Other Important Information from FDA: 2007-12-03
• Review: 2010-01-05
• Summary Review: 2010-01-05

Application Sponsors

NDA 022172

ASTRAZENECA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	50MG	0	SEROQUEL XR	QUETIAPINE FUMARATE
002	TABLET, EXTENDED RELEASE; ORAL	200MG	0	SEROQUEL XR	QUETIAPINE FUMARATE
003	TABLET, EXTENDED RELEASE; ORAL	300MG	0	SEROQUEL XR	QUETIAPINE FUMARATE
004	TABLET, EXTENDED RELEASE; ORAL	400MG	0	SEROQUEL XR	QUETIAPINE FUMARATE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2007-11-15

STANDARD

CDER Filings

ASTRAZENECA

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(
    [0] => Array
        (
            [ApplNo] => 22172
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SEROQUEL XR","activeIngredients":"QUETIAPINE FUMARATE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022172lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"50MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SEROQUEL XR","submission":"QUETIAPINE FUMARATE","actionType":"400MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-11-15
        )

)