ANDA 091327

ATHEM

FDA Drug Application

Application #091327

Application Sponsors

ANDA 091327

ATHEM

Marketing Status

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

Application Products

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

FDA Submissions

ORIG

1

AP

2011-10-17

Submissions Property Types

ORIG

1

Null

7

CDER Filings

BAJAJ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91327
            [companyName] => BAJAJ
            [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
        )

)