WATSON LABS TEVA FDA Approval ANDA 203959

ANDA 203959

WATSON LABS TEVA

FDA Drug Application

Application #203959

Application Sponsors

ANDA 203959WATSON LABS TEVA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2017-04-18

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203959
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-18
        )

)

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