HIKMA FDA Approval ANDA 205274

ANDA 205274

HIKMA

FDA Drug Application

Application #205274

Application Sponsors

ANDA 205274HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, CHEWABLE;ORAL125MG0AMOXICILLINAMOXICILLIN
002TABLET, CHEWABLE;ORAL250MG0AMOXICILLINAMOXICILLIN

FDA Submissions

UNKNOWN; ORIG1AP2020-06-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205274
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"125MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"250MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-25
        )

)

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