AIZANT FDA Approval ANDA 211390

ANDA 211390

AIZANT

FDA Drug Application

Application #211390

Application Sponsors

ANDA 211390AIZANT

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL600MG0ZILEUTONZILEUTON

FDA Submissions

UNKNOWN; ORIG1AP2020-10-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AIZANT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211390
            [companyName] => AIZANT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZILEUTON","activeIngredients":"ZILEUTON","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-23
        )

)

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