ANDA 208939

HETERO LABS LTD III

FDA Drug Application

Application #208939

Application Sponsors

ANDA 208939

HETERO LABS LTD III

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

2020-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208939
            [companyName] => HETERO LABS LTD III
            [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\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)