ANDA 214330

NOVITIUM PHARMA

FDA Drug Application

Application #214330

Application Sponsors

ANDA 214330

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML;40MG/5ML

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214330
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"200MG\/5ML;40MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)