ANDA 211830

APOTEX

FDA Drug Application

Application #211830

Documents

• Letter: 2019-10-03

Application Sponsors

ANDA 211830

APOTEX

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

2019-08-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211830
            [companyName] => APOTEX
            [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":"08\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211830Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-22
        )

)