CARNEGIE FDA Approval ANDA 215402

ANDA 215402

CARNEGIE

FDA Drug Application

Application #215402

Application Sponsors

ANDA 215402CARNEGIE

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL100MG0ETRAVIRINEETRAVIRINE
002TABLET;ORAL200MG0ETRAVIRINEETRAVIRINE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CARNEGIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215402
            [companyName] => CARNEGIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-13
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.