TORRENT FDA Approval ANDA 090474

ANDA 090474

TORRENT

FDA Drug Application

Application #090474

Application Sponsors

ANDA 090474TORRENT

Marketing Status

Discontinued001
Discontinued002

Application Products

001SYRUP;ORAL5MG/5ML0CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE
002SYRUP;ORAL5MG/5ML0CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-03-30

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90474
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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