ANDA 211443

APOTEX

FDA Drug Application

Application #211443

Application Sponsors

ANDA 211443

APOTEX

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211443
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-13
        )

)