ANDA 212924

ALKEM LABS LTD

FDA Drug Application

Application #212924

Application Sponsors

ANDA 212924

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	40MG	0	FEBUXOSTAT	FEBUXOSTAT
002	TABLET;ORAL	80MG	0	FEBUXOSTAT	FEBUXOSTAT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212924
            [companyName] => ALKEM LABS LTD
            [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":"12\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-07
        )

)