LANNETT CO INC FDA Approval ANDA 203046

ANDA 203046

LANNETT CO INC

FDA Drug Application

Application #203046

Application Sponsors

ANDA 203046LANNETT CO INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL15MG0CODEINE SULFATECODEINE SULFATE
002TABLET;ORAL30MG0CODEINE SULFATECODEINE SULFATE
003TABLET;ORAL60MG0CODEINE SULFATECODEINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2014-06-13
REMS; REMSSUPPL7AP2018-09-18

Submissions Property Types

ORIG1Null15
SUPPL7Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203046
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CODEINE SULFATE","activeIngredients":"CODEINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CODEINE SULFATE","activeIngredients":"CODEINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CODEINE SULFATE","activeIngredients":"CODEINE SULFATE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/13\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-7","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)

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