ANDA 209716

AMNEAL PHARMS NY

FDA Drug Application

Application #209716

Application Sponsors

ANDA 209716

AMNEAL PHARMS NY

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

2019-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209716
            [companyName] => AMNEAL PHARMS NY
            [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":"06\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-05
        )

)