IMPAX LABS FDA Approval ANDA 084541

ANDA 084541

IMPAX LABS

FDA Drug Application

Application #084541

Application Sponsors

ANDA 084541IMPAX LABS

Marketing Status

Discontinued002

Application Products

002TABLET;ORAL15MG0PROPANTHELINE BROMIDEPROPANTHELINE BROMIDE

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84541
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPANTHELINE BROMIDE","activeIngredients":"PROPANTHELINE BROMIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPANTHELINE BROMIDE","submission":"PROPANTHELINE BROMIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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