ANDA 202039

AUROLIFE PHARMA LLC

FDA Drug Application

Application #202039

Application Sponsors

ANDA 202039

AUROLIFE PHARMA LLC

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002
• Over-the-counter: 003

Application Products

001	TABLET;ORAL	30MG	0	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE
002	TABLET;ORAL	60MG	0	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE
003	TABLET;ORAL	180MG	0	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-09-15	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202039
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"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":"11\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/15\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-09-15
        )

)