MACLEODS PHARMS LTD FDA Approval ANDA 207293

ANDA 207293

MACLEODS PHARMS LTD

FDA Drug Application

Application #207293

Application Sponsors

ANDA 207293MACLEODS PHARMS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL40MG0FEBUXOSTATFEBUXOSTAT
002TABLET;ORAL80MG0FEBUXOSTATFEBUXOSTAT

FDA Submissions

UNKNOWN; ORIG1TA2017-07-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207293
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-28
        )

)

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