ANDA 215478

UNICHEM

FDA Drug Application

Application #215478

Application Sponsors

ANDA 215478

UNICHEM

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

UNKNOWN;

ORIG

1

AP

2022-08-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

UNICHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215478
            [companyName] => UNICHEM
            [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] => 
            [originalApprovals] => [{"actionDate":"08\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-15
        )

)