APPCO FDA Approval ANDA 214609

ANDA 214609

APPCO

FDA Drug Application

Application #214609

Application Sponsors

ANDA 214609APPCO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 150MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 225MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APPCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214609
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 225MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-30
        )

)

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