ANDA 213105

CATALENT

FDA Drug Application

Application #213105

Application Sponsors

ANDA 213105

CATALENT

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

10MG

0

CETIRIZINE HYDROCHLORIDE ALLERGY

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

CATALENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213105
            [companyName] => CATALENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-21
        )

)