ANDA 090922

SUN PHARM INDS LTD

FDA Drug Application

Application #090922

Documents

• Review: 2015-11-17

Application Sponsors

ANDA 090922

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

5MG;120MG

0

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2012-09-28

Submissions Property Types

ORIG

1

Null

15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90922
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"5MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"5MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)