ANDA 074835

AUROLIFE PHARMA LLC

FDA Drug Application

Application #074835

Application Sponsors

ANDA 074835

AUROLIFE PHARMA LLC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 10MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 25MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 50MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE
004	CAPSULE;ORAL	EQ 75MG BASE	0	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

1997-06-30

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74835
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORTRIPTYLINE HYDROCHLORIDE","activeIngredients":"NORTRIPTYLINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORTRIPTYLINE HYDROCHLORIDE","submission":"NORTRIPTYLINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)