ANDA 090482

PAR PHARM

FDA Drug Application

Application #090482

Documents

• Letter: 2017-06-21
• Label: 2017-05-15

Application Sponsors

ANDA 090482

PAR PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
005	TABLET, EXTENDED RELEASE;ORAL	EQ 400MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE

FDA Submissions

ORIG

1

AP

2017-05-09

Submissions Property Types

ORIG

1

Null

3

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90482
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/090482Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 400MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-05-09
        )

)