IGI LABS INC FDA Approval ANDA 063169

ANDA 063169

IGI LABS INC

FDA Drug Application

Application #063169

Application Sponsors

ANDA 063169IGI LABS INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 250MG BASE/ML0AMIKACIN SULFATEAMIKACIN SULFATE

CDER Filings

IGI LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63169
            [companyName] => IGI LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 250MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIKACIN SULFATE","submission":"AMIKACIN SULFATE","actionType":"EQ 250MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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