ANDA 209339

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209339

Application Sponsors

ANDA 209339

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE, DELAYED RELEASE;ORAL

EQ 20MG BASE

0

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-01-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	6	Null	15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209339
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/15\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-15
        )

)