ANDA 210622

HETERO LABS LTD III

FDA Drug Application

Application #210622

Application Sponsors

ANDA 210622

HETERO LABS LTD III

Marketing Status

• Over-the-counter: 001

Application Products

001

SYRUP;ORAL

5MG/5ML

0

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210622
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-13
        )

)