MACLEODS PHARMS LTD FDA Approval ANDA 203359

ANDA 203359

MACLEODS PHARMS LTD

FDA Drug Application

Application #203359

Application Sponsors

ANDA 203359MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORALEQ 25MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
002TABLET;ORALEQ 50MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
003TABLET;ORALEQ 100MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
004TABLET;ORALEQ 200MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
005TABLET;ORALEQ 300MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE
006TABLET;ORALEQ 400MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-17
LABELING; LabelingSUPPL2AP2017-06-30STANDARD
LABELING; LabelingSUPPL3AP2017-06-30STANDARD
LABELING; LabelingSUPPL9AP2019-12-06STANDARD
LABELING; LabelingSUPPL13AP2019-12-06STANDARD
LABELING; LabelingSUPPL14AP2021-11-09STANDARD
LABELING; LabelingSUPPL15AP2021-11-09STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null15
SUPPL9Null7
SUPPL13Null15
SUPPL14Null7
SUPPL15Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203359
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/06\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-06
        )

)

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