ANDA 200274

APOTEX INC

FDA Drug Application

Application #200274

Application Sponsors

ANDA 200274

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

BICALUTAMIDE

BICALUTAMIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-05-21
LABELING; Labeling	SUPPL	2	AP	2019-04-04	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200274
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-04
        )

)