ANDA 212260

NOVITIUM PHARMA

FDA Drug Application

Application #212260

Documents

• Letter: 2019-06-19

Application Sponsors

ANDA 212260

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 10MG BASE/ML

0

SILDENAFIL CITRATE

SILDENAFIL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212260
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212260Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-31
        )

)