ANDA 090182

TARO

FDA Drug Application

Application #090182

Application Sponsors

ANDA 090182

TARO

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2008-04-22
LABELING; Labeling	SUPPL	2	AP	2009-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2011-10-01
LABELING; Labeling	SUPPL	14	AP	2013-05-28
LABELING; Labeling	SUPPL	21	AP	2015-04-13	STANDARD

Submissions Property Types

SUPPL	7	Null	15
SUPPL	14	Null	15
SUPPL	21	Null	15

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90182
            [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":"CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)