DEXCEL PHARMA FDA Approval ANDA 213927

ANDA 213927

DEXCEL PHARMA

FDA Drug Application

Application #213927

Application Sponsors

ANDA 213927DEXCEL PHARMA

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 75MG BASE0VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

DEXCEL PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213927
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENLAFAXINE HYDROCHLORIDE","activeIngredients":"VENLAFAXINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)

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