ANDA 090757

ANCHEN PHARMS

FDA Drug Application

Application #090757

Application Sponsors

ANDA 090757

ANCHEN PHARMS

Marketing Status

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

Application Products

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

FDA Submissions

ORIG

1

AP

2017-12-01

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90757
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 400MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)