ANDA 202204

HIKMA

FDA Drug Application

Application #202204

Application Sponsors

ANDA 202204

HIKMA

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

DUTASTERIDE

DUTASTERIDE

FDA Submissions

ORIG

1

AP

2015-11-23

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202204
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-04
        )

)