ANDA 201546

TARO

FDA Drug Application

Application #201546

Application Sponsors

ANDA 201546

TARO

Marketing Status

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

Application Products

001	SYRUP;ORAL	5MG/5ML	0	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE
002	SYRUP;ORAL	5MG/5ML	0	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-04-06

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201546
            [companyName] => TARO
            [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"},{"drugName":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/07\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-04-06
        )

)