ALVOGEN FDA Approval ANDA 091681

ANDA 091681

ALVOGEN

FDA Drug Application

Application #091681

Application Sponsors

ANDA 091681ALVOGEN

Marketing Status

Prescription001

Application Products

001TABLET;ORAL250MG0DISULFIRAMDISULFIRAM

FDA Submissions

N/A; Not ApplicableORIG1AP2013-08-08

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB

CDER Filings

ALVOGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91681
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISULFIRAM","activeIngredients":"DISULFIRAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISULFIRAM","submission":"DISULFIRAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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