ANDA 210596

PRINSTON INC

FDA Drug Application

Application #210596

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 210596

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 5MG BASE;80MG

0

VYDUO

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210596
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYDUO","activeIngredients":"NEBIVOLOL HYDROCHLORIDE; VALSARTAN","strength":"EQ 5MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-19
        )

)