ANNORA PHARMA FDA Approval ANDA 215742

ANDA 215742

ANNORA PHARMA

FDA Drug Application

Application #215742

Application Sponsors

ANDA 215742ANNORA PHARMA

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL600MG0ZILEUTONZILEUTON

FDA Submissions

UNKNOWN; ORIG1AP2022-10-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215742
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZILEUTON","activeIngredients":"ZILEUTON","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-11
        )

)

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