ANDA 077498

SUN PHARM INDS LTD

FDA Drug Application

Application #077498

Documents

• Letter: 2008-01-09
• Label: 2008-01-08

Application Sponsors

ANDA 077498

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002
• Over-the-counter: 003
• Over-the-counter: 004

Application Products

001	TABLET;ORAL	5MG	0	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE
003	TABLET;ORAL	5MG	0	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE
004	TABLET;ORAL	10MG	0	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-12-27
LABELING; Labeling	SUPPL	5	AP	2011-02-15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77498
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CETIRIZINE HYDROCHLORIDE HIVES","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/077498lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE ALLERGY","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CETIRIZINE HYDROCHLORIDE HIVES","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-12-27
        )

)