ANDA 208481

APOTEX

FDA Drug Application

Application #208481

Application Sponsors

ANDA 208481

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

ITRACONAZOLE

ITRACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208481
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-02
        )

)