ANDA 210722

GRANULES INDIA LTD

FDA Drug Application

Application #210722

Application Sponsors

ANDA 210722

GRANULES INDIA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

10MG

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GRANULES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210722
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)