ANDA 216448

NOVITIUM PHARMA

FDA Drug Application

Application #216448

Application Sponsors

ANDA 216448

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216448
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-09
        )

)