ANDA 085303

ROCHE

FDA Drug Application

Application #085303

Application Sponsors

ANDA 085303

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

150MG

0

ENDEP

AMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-12-27
LABELING; Labeling	SUPPL	21	AP	1995-01-17

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85303
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)