UNICHEM FDA Approval ANDA 215478

ANDA 215478

UNICHEM

FDA Drug Application

Application #215478

Application Sponsors

ANDA 215478UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 50MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
002TABLET, EXTENDED RELEASE;ORALEQ 150MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
003TABLET, EXTENDED RELEASE;ORALEQ 200MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
004TABLET, EXTENDED RELEASE;ORALEQ 300MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
005TABLET, EXTENDED RELEASE;ORALEQ 400MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

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
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.