EYWA FDA Approval ANDA 212589

ANDA 212589

EYWA

FDA Drug Application

Application #212589

Documents

Letter2021-10-08

Application Sponsors

ANDA 212589EYWA

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL324MG0QUINIDINE GLUCONATEQUINIDINE GLUCONATE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

EYWA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212589
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE GLUCONATE","activeIngredients":"QUINIDINE GLUCONATE","strength":"324MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-17
        )

)

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