INGENUS PHARMS LLC FDA Approval ANDA 213836

ANDA 213836

INGENUS PHARMS LLC

FDA Drug Application

Application #213836

Application Sponsors

ANDA 213836INGENUS PHARMS LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL800MG0METAXALONEMETAXALONE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

INGENUS PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213836
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METAXALONE","activeIngredients":"METAXALONE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.