ANDA 210107

ZYDUS

FDA Drug Application

Application #210107

Application Sponsors

ANDA 210107

ZYDUS

Marketing Status

• Discontinued: 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

2019-06-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210107
            [companyName] => ZYDUS
            [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":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-14
        )

)