HIKMA FDA Approval ANDA 205414

ANDA 205414

HIKMA

FDA Drug Application

Application #205414

Documents

Letter2016-12-15

Application Sponsors

ANDA 205414HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL40MG0FEBUXOSTATFEBUXOSTAT
002TABLET;ORAL80MG0FEBUXOSTATFEBUXOSTAT

FDA Submissions

UNKNOWN; ORIG1AP2019-10-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205414
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205414Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-15
        )

)

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