AM REGENT FDA Approval ANDA 077906

ANDA 077906

AM REGENT

FDA Drug Application

Application #077906

Application Sponsors

ANDA 077906AM REGENT

Marketing Status

Prescription001

Application Products

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

FDA Submissions

ORIG1AP2007-05-15

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77906
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAFFEINE CITRATE","activeIngredients":"CAFFEINE CITRATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAFFEINE CITRATE","submission":"CAFFEINE CITRATE","actionType":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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