PRINSTON INC FDA Approval ANDA 212682

ANDA 212682

PRINSTON INC

FDA Drug Application

Application #212682

Application Sponsors

ANDA 212682PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 2.5MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
002TABLET;ORALEQ 5MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
003TABLET;ORALEQ 10MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
004TABLET;ORALEQ 20MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212682
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-07
        )

)

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