ANDA 209274

GRANULES INDIA LTD

FDA Drug Application

Application #209274

Application Sponsors

ANDA 209274

GRANULES INDIA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

10MG

0

CETIRIZINE HYDROCHLORIDE ALLERGY

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GRANULES INDIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209274
            [companyName] => GRANULES INDIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE ALLERGY","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)