NOVITIUM PHARMA FDA Approval ANDA 215003

ANDA 215003

NOVITIUM PHARMA

FDA Drug Application

Application #215003

Application Sponsors

ANDA 215003NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORALEQ 10MG BASE/5ML0PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215003
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-03
        )

)

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