ANDA 083639

ROCHE

FDA Drug Application

Application #083639

Application Sponsors

ANDA 083639

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	10MG	0	ENDEP	AMITRIPTYLINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	ENDEP	AMITRIPTYLINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	ENDEP	AMITRIPTYLINE HYDROCHLORIDE
004	TABLET;ORAL	75MG	0	ENDEP	AMITRIPTYLINE HYDROCHLORIDE
005	TABLET;ORAL	100MG	0	ENDEP	AMITRIPTYLINE HYDROCHLORIDE

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83639
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENDEP","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENDEP","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)