IMPAX LABS FDA Approval ANDA 083317

ANDA 083317

IMPAX LABS

FDA Drug Application

Application #083317

Application Sponsors

ANDA 083317IMPAX LABS

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL65MG0PROPOXYPHENE HYDROCHLORIDEPROPOXYPHENE HYDROCHLORIDE

FDA Submissions

ORIG1AP1973-10-23

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83317
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPOXYPHENE HYDROCHLORIDE","activeIngredients":"PROPOXYPHENE HYDROCHLORIDE","strength":"65MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPOXYPHENE HYDROCHLORIDE","submission":"PROPOXYPHENE HYDROCHLORIDE","actionType":"65MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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