LANNETT CO INC FDA Approval ANDA 201463

ANDA 201463

LANNETT CO INC

FDA Drug Application

Application #201463

Application Sponsors

ANDA 201463LANNETT CO INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL2.5MG0DRONABINOLDRONABINOL
002CAPSULE;ORAL5MG0DRONABINOLDRONABINOL
003CAPSULE;ORAL10MG0DRONABINOLDRONABINOL

FDA Submissions

N/A; Not ApplicableORIG1AP2018-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2021-06-14STANDARD

Submissions Property Types

ORIG1Null7
SUPPL6Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201463
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)

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