ANDA 215043

NOVITIUM PHARMA

FDA Drug Application

Application #215043

Application Sponsors

ANDA 215043

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

40MG/5ML

0

FAMOTIDINE

FAMOTIDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215043
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-20
        )

)