TRIS PHARMA INC FDA Approval ANDA 090572

ANDA 090572

TRIS PHARMA INC

FDA Drug Application

Application #090572

Application Sponsors

ANDA 090572TRIS PHARMA INC

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

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

FDA Submissions

ORIG1AP2012-11-16

Submissions Property Types

ORIG1Null15

CDER Filings

TRIS PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90572
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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