SUN PHARM INDS LTD FDA Approval ANDA 077498

ANDA 077498

SUN PHARM INDS LTD

FDA Drug Application

Application #077498

Documents

Letter2008-01-09
Label2008-01-08

Application Sponsors

ANDA 077498SUN PHARM INDS LTD

Marketing Status

Over-the-counter001
Over-the-counter002
Over-the-counter003
Over-the-counter004

Application Products

001TABLET;ORAL5MG0CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE
002TABLET;ORAL10MG0CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE
003TABLET;ORAL5MG0CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE
004TABLET;ORAL10MG0CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2007-12-27
LABELING; LabelingSUPPL5AP2011-02-15

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
        )

)

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