ANCHEN PHARMS FDA Approval ANDA 078087

ANDA 078087

ANCHEN PHARMS

FDA Drug Application

Application #078087

Application Sponsors

ANDA 078087ANCHEN PHARMS

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001CAPSULE, EXTENDED RELEASE;ORALEQ 37.5MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORALEQ 75MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORALEQ 150MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2012-03-16
LABELING; LabelingSUPPL3AP2015-09-17STANDARD
LABELING; LabelingSUPPL5AP2015-09-17STANDARD
LABELING; LabelingSUPPL7AP2015-09-17STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL5Null15
SUPPL7Null15

CDER Filings

ANCHEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78087
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 37.5MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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