ANDA 078057

IMPAX LABS

FDA Drug Application

Application #078057

Application Sponsors

ANDA 078057

IMPAX LABS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	CAPSULE, EXTENDED RELEASE; ORAL	37.5MG	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE; ORAL	75MG	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE; ORAL	150MG	0	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE

FDA Submissions

ORIG

1

TA

2007-10-16

Submissions Property Types

ORIG

1

Null

0

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78057
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"CAPSULE, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"75MG","submissionClassification":"CAPSULE, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)