TEVA PHARMS USA INC FDA Approval ANDA 211897

ANDA 211897

TEVA PHARMS USA INC

FDA Drug Application

Application #211897

Application Sponsors

ANDA 211897TEVA PHARMS USA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-08-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211897
            [companyName] => TEVA PHARMS USA INC
            [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":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)

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