AGGREGA FDA Approval ANDA 215409

ANDA 215409

AGGREGA

FDA Drug Application

Application #215409

Application Sponsors

ANDA 215409AGGREGA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL250MG0PENICILLAMINEPENICILLAMINE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AGGREGA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215409
            [companyName] => AGGREGA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-23
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.