ANDA 204292

APOTEX INC

FDA Drug Application

Application #204292

Application Sponsors

ANDA 204292

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

DUTASTERIDE

DUTASTERIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-11-24
LABELING; Labeling	SUPPL	3	AP	2022-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204292
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-24
        )

)