ANDA 203964

BRECKENRIDGE

FDA Drug Application

Application #203964

Application Sponsors

ANDA 203964

BRECKENRIDGE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	0	LANSOPRAZOLE	LANSOPRAZOLE
002	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	0	LANSOPRAZOLE	LANSOPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-17

Submissions Property Types

ORIG

1

Null

15

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203964
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-17
        )

)