ANDA 203796

HIKMA PHARMS

FDA Drug Application

Application #203796

Application Sponsors

ANDA 203796

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

LETROZOLE

LETROZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-03

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203796
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-03
        )

)