NIVAGEN PHARMS INC FDA Approval ANDA 213328

ANDA 213328

NIVAGEN PHARMS INC

FDA Drug Application

Application #213328

Application Sponsors

ANDA 213328NIVAGEN PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE;ORAL5MG0TEMOZOLOMIDETEMOZOLOMIDE
002CAPSULE;ORAL20MG0TEMOZOLOMIDETEMOZOLOMIDE
003CAPSULE;ORAL100MG0TEMOZOLOMIDETEMOZOLOMIDE
004CAPSULE;ORAL140MG0TEMOZOLOMIDETEMOZOLOMIDE
005CAPSULE;ORAL180MG0TEMOZOLOMIDETEMOZOLOMIDE
006CAPSULE;ORAL250MG0TEMOZOLOMIDETEMOZOLOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

NIVAGEN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213328
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-23
        )

)

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