ANDA 085749

ROCHE

FDA Drug Application

Application #085749

Application Sponsors

ANDA 085749

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

CONCENTRATE;ORAL

40MG/ML

0

ENDEP

AMITRIPTYLINE HYDROCHLORIDE

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85749
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"40MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"40MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)