ANDA 085935

UCB INC

FDA Drug Application

Application #085935

Application Sponsors

ANDA 085935

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85935
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)