TORRENT FDA Approval ANDA 210634

ANDA 210634

TORRENT

FDA Drug Application

Application #210634

Application Sponsors

ANDA 210634TORRENT

Marketing Status

Discontinued001

Application Products

001SYRUP;ORAL10MG/5ML0HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-26STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210634
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-26
        )

)

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