LANNETT CO INC FDA Approval ANDA 212094

ANDA 212094

LANNETT CO INC

FDA Drug Application

Application #212094

Application Sponsors

ANDA 212094LANNETT CO INC

Marketing Status

Prescription001

Application Products

001CONCENTRATE;ORAL10MG/ML0METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212094
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-03
        )

)

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