ANDA 212094

LANNETT CO INC

FDA Drug Application

Application #212094

Application Sponsors

ANDA 212094

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

CONCENTRATE;ORAL

10MG/ML

0

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

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
        )

)