LANNETT CO INC FDA Approval ANDA 207157

ANDA 207157

LANNETT CO INC

FDA Drug Application

Application #207157

Application Sponsors

ANDA 207157LANNETT CO INC

Marketing Status

Over-the-counter001

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2017-09-29STANDARD
LABELING; LabelingSUPPL2AP2020-10-08STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207157
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-29
        )

)

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