TORRENT FDA Approval ANDA 090102

ANDA 090102

TORRENT

FDA Drug Application

Application #090102

Application Sponsors

ANDA 090102TORRENT

Marketing Status

Discontinued001

Application Products

001SYRUP;ORALEQ 15MG BASE/ML0RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-05-26
LABELING; LabelingSUPPL2AP2010-04-30

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90102
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 15MG BASE\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 15MG BASE\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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