ANDA 078617

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #078617

Application Sponsors

ANDA 078617

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

5MG/5ML

0

CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2010-02-02

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78617
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)