ANDA 201503

APOTEX CORP

FDA Drug Application

Application #201503

Application Sponsors

ANDA 201503

APOTEX CORP

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.5MG

0

CABERGOLINE

CABERGOLINE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-03-08

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201503
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABERGOLINE","activeIngredients":"CABERGOLINE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-03-08
        )

)