ANDA 207673

DR REDDYS LABS LTD

FDA Drug Application

Application #207673

Application Sponsors

ANDA 207673

DR REDDYS LABS 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	2018-05-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207673
            [companyName] => DR REDDYS LABS 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":"05\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-21
        )

)