ANDA 211571

DR REDDYS LABS LTD

FDA Drug Application

Application #211571

Documents

• Letter: 2020-06-04

Application Sponsors

ANDA 211571

DR REDDYS LABS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

EQ 20MG BASE

0

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211571
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211571Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)