BIONPHARMA INC FDA Approval ANDA 209754

ANDA 209754

BIONPHARMA INC

FDA Drug Application

Application #209754

Application Sponsors

ANDA 209754BIONPHARMA INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
002TABLET;ORAL10MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-03-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209754
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-24
        )

)

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