PRINSTON INC FDA Approval ANDA 210596

ANDA 210596

PRINSTON INC

FDA Drug Application

Application #210596

Documents

Letter2022-11-28

Application Sponsors

ANDA 210596PRINSTON INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 5MG BASE;80MG0VYDUONEBIVOLOL HYDROCHLORIDE; VALSARTAN

FDA Submissions

UNKNOWN; ORIG1AP2022-09-19STANDARD

Submissions Property Types

ORIG1Null7

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
        )

)

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