ANDA 215003

NOVITIUM PHARMA

FDA Drug Application

Application #215003

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 215003

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

EQ 10MG BASE/5ML

0

PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-09-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

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
        )

)