PRINSTON INC FDA Approval ANDA 090027

ANDA 090027

PRINSTON INC

FDA Drug Application

Application #090027

Application Sponsors

ANDA 090027PRINSTON INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001TABLET;ORALEQ 25MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
002TABLET;ORALEQ 37.5MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
003TABLET;ORALEQ 50MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
004TABLET;ORALEQ 75MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
005TABLET;ORALEQ 100MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2010-08-04
LABELING; LabelingSUPPL4AP2012-10-16STANDARD
LABELING; LabelingSUPPL6AP2013-07-26STANDARD
LABELING; LabelingSUPPL9AP2014-07-17STANDARD
LABELING; LabelingSUPPL12AP2017-01-04STANDARD
LABELING; LabelingSUPPL14AP2020-04-14STANDARD
LABELING; LabelingSUPPL15AP2021-09-21STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15
SUPPL6Null15
SUPPL9Null15
SUPPL12Null7
SUPPL14Null7
SUPPL15Null7

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90027
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 37.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENLAFAXINE HYDROCHLORIDE","submission":"VENLAFAXINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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