RICONPHARMA LLC FDA Approval ANDA 213763

ANDA 213763

RICONPHARMA LLC

FDA Drug Application

Application #213763

Application Sponsors

ANDA 213763RICONPHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE
002TABLET;ORAL10MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-24STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

RICONPHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213763
            [companyName] => RICONPHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPHETAMINE SULFATE","submission":"AMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMPHETAMINE SULFATE","submission":"AMPHETAMINE SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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