ANDA 210070

APOTEX

FDA Drug Application

Application #210070

Application Sponsors

ANDA 210070

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

OMEPRAZOLE

OMEPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210070
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-01
        )

)