ANDA 210137

UNIQUE PHARM LABS

FDA Drug Application

Application #210137

Application Sponsors

ANDA 210137

UNIQUE PHARM LABS

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

180MG

0

FEXOFENADINE HYDROCHLORIDE ALLERGY

FEXOFENADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

UNIQUE PHARM LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210137
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-13
        )

)