LANNETT CO INC FDA Approval ANDA 207414

ANDA 207414

LANNETT CO INC

FDA Drug Application

Application #207414

Application Sponsors

ANDA 207414LANNETT CO INC

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;ORAL5MG/5ML0METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE
002SOLUTION;ORAL10MG/5ML0METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207414
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)

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