ANDA 203046

LANNETT CO INC

FDA Drug Application

Application #203046

Application Sponsors

ANDA 203046

LANNETT CO INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	15MG	0	CODEINE SULFATE	CODEINE SULFATE
002	TABLET;ORAL	30MG	0	CODEINE SULFATE	CODEINE SULFATE
003	TABLET;ORAL	60MG	0	CODEINE SULFATE	CODEINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-06-13
REMS; REMS	SUPPL	7	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)