ANDA 207157

LANNETT CO INC

FDA Drug Application

Application #207157

Application Sponsors

ANDA 207157

LANNETT CO INC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

15MG

0

LANSOPRAZOLE

LANSOPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-10-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

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
        )

)