GRANULES INDIA LTD FDA Approval ANDA 213663

ANDA 213663

GRANULES INDIA LTD

FDA Drug Application

Application #213663

Application Sponsors

ANDA 213663GRANULES INDIA LTD

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL25MG;220MG0NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-09-24STANDARD

Submissions Property Types

ORIG1Null15

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
        )

)

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