ANDA 215458

MANKIND PHARMA

FDA Drug Application

Application #215458

Application Sponsors

ANDA 215458

MANKIND PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

0

OMEGA-3-ACID ETHYL ESTERS

OMEGA-3-ACID ETHYL ESTERS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MANKIND PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215458
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEGA-3-ACID ETHYL ESTERS","activeIngredients":"OMEGA-3-ACID ETHYL ESTERS","strength":"1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-15
        )

)