ANDA 211075

GRANULES INDIA LTD

FDA Drug Application

Application #211075

Application Sponsors

ANDA 211075

GRANULES INDIA LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	60MG	0	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE
002	TABLET;ORAL	180MG	0	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GRANULES INDIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211075
            [companyName] => GRANULES INDIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-18
        )

)