PRINSTON PHARMA INC FDA Approval ANDA 206266

ANDA 206266

PRINSTON PHARMA INC

FDA Drug Application

Application #206266

Application Sponsors

ANDA 206266PRINSTON PHARMA INC

Marketing Status

None (Tentative Approval)001
Prescription002

Application Products

001TABLET;ORAL40MG0FEBUXOSTATFEBUXOSTAT
002TABLET;ORAL80MG0FEBUXOSTATFEBUXOSTAT

FDA Submissions

UNKNOWN; ORIG1TA2018-05-31STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206266
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-31
        )

)

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