TEVA PHARMS USA INC FDA Approval ANDA 209956

ANDA 209956

TEVA PHARMS USA INC

FDA Drug Application

Application #209956

Application Sponsors

ANDA 209956TEVA PHARMS USA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL1MG0POMALIDOMIDEPOMALIDOMIDE
002CAPSULE;ORAL2MG0POMALIDOMIDEPOMALIDOMIDE
003CAPSULE;ORAL3MG0POMALIDOMIDEPOMALIDOMIDE
004CAPSULE;ORAL4MG0POMALIDOMIDEPOMALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209956
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-04
        )

)

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