UNICHEM FDA Approval ANDA 211819

ANDA 211819

UNICHEM

FDA Drug Application

Application #211819

Documents

Letter2021-03-10

Application Sponsors

ANDA 211819UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG0APREMILASTAPREMILAST
002TABLET;ORAL20MG0APREMILASTAPREMILAST
003TABLET;ORAL30MG0APREMILASTAPREMILAST

FDA Submissions

UNKNOWN; ORIG1AP2021-02-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211819
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-17
        )

)

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