ANDA 213663

GRANULES INDIA LTD

FDA Drug Application

Application #213663

Application Sponsors

ANDA 213663

GRANULES INDIA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

25MG;220MG

0

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GRANULES INDIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213663
            [companyName] => GRANULES INDIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM","strength":"25MG;220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)