PURACAP PHARM LLC FDA Approval ANDA 210093

ANDA 210093

PURACAP PHARM LLC

FDA Drug Application

Application #210093

Application Sponsors

ANDA 210093PURACAP PHARM LLC

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; ORIG1AP2020-06-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

PURACAP PHARM LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210093
            [companyName] => PURACAP PHARM LLC
            [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":"06\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-15
        )

)

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