ANDA 209457

HIKMA

FDA Drug Application

Application #209457

Documents

• Letter: 2020-06-04

Application Sponsors

ANDA 209457

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

1GM

0

ICOSAPENT ETHYL

ICOSAPENT ETHYL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209457
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICOSAPENT ETHYL","activeIngredients":"ICOSAPENT ETHYL","strength":"1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-21
        )

)