APPCO FDA Approval ANDA 212047

ANDA 212047

APPCO

FDA Drug Application

Application #212047

Application Sponsors

ANDA 212047APPCO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL375MG0CHLORZOXAZONECHLORZOXAZONE
002TABLET;ORAL750MG0CHLORZOXAZONECHLORZOXAZONE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APPCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212047
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-27
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.