AM REGENT FDA Approval ANDA 090064

ANDA 090064

AM REGENT

FDA Drug Application

Application #090064

Application Sponsors

ANDA 090064AM REGENT

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORALEQ 30MG BASE/3ML (EQ 10MG BASE/ML)0CAFFEINE CITRATECAFFEINE CITRATE

FDA Submissions

ORIG1AP2009-11-20

Submissions Property Types

ORIG1Null7

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90064
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAFFEINE CITRATE","activeIngredients":"CAFFEINE CITRATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAFFEINE CITRATE","submission":"CAFFEINE CITRATE","actionType":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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