GLW FDA Approval ANDA 212504

ANDA 212504

GLW

FDA Drug Application

Application #212504

Application Sponsors

ANDA 212504GLW

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS0OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS

FDA Submissions

UNKNOWN; ORIG1AP2020-08-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

GLW
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212504
            [companyName] => GLW
            [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":"08\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-19
        )

)

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