APPCO FDA Approval ANDA 211372

ANDA 211372

APPCO

FDA Drug Application

Application #211372

Application Sponsors

ANDA 211372APPCO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL125MG0ACETAZOLAMIDEACETAZOLAMIDE
002TABLET;ORAL250MG0ACETAZOLAMIDEACETAZOLAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APPCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211372
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-22
        )

)

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