ANDA 213513

HETERO LABS LTD III

FDA Drug Application

Application #213513

Application Sponsors

ANDA 213513

HETERO LABS LTD III

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213513
            [companyName] => HETERO LABS LTD III
            [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\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-29
        )

)