ANDA 084923

IMPAX LABS

FDA Drug Application

Application #084923

Application Sponsors

ANDA 084923

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84923
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)