ANDA 211717

EUGIA PHARMA

FDA Drug Application

Application #211717

Application Sponsors

ANDA 211717

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

LETROZOLE

LETROZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211717
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-11
        )

)