ANDA 208123

TARO

FDA Drug Application

Application #208123

Application Sponsors

ANDA 208123

TARO

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SUSPENSION;ORAL	30MG/5ML	0	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE
002	SUSPENSION;ORAL	30MG/5ML	0	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208123
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-09
        )

)