ANDA 202384

LUPIN LTD

FDA Drug Application

Application #202384

Application Sponsors

ANDA 202384

LUPIN LTD

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

40MG

0

OMEPRAZOLE

OMEPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-25
LABELING; Labeling	SUPPL	2	AP	2018-06-07	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202384
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"40MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/31\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-06-07
        )

)