AUROBINDO PHARMA LTD FDA Approval ANDA 211695

ANDA 211695

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211695

Application Sponsors

ANDA 211695AUROBINDO PHARMA LTD

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL250MG;250MG;65MG0ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211695
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, ASPIRIN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; ASPIRIN; CAFFEINE","strength":"250MG;250MG;65MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.