ANDA 085376

IMPAX LABS

FDA Drug Application

Application #085376

Application Sponsors

ANDA 085376

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.75MG

0

DEXAMETHASONE

DEXAMETHASONE

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85376
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)