GLAXOSMITHKLINE FDA Approval ANDA 061866

ANDA 061866

GLAXOSMITHKLINE

FDA Drug Application

Application #061866

Application Sponsors

ANDA 061866GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001FOR SUSPENSION;ORAL125MG/5ML0ANSPORCEPHRADINE
002FOR SUSPENSION;ORAL250MG/5ML0ANSPORCEPHRADINE

FDA Submissions

ORIG1AP1974-10-15

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61866
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANSPOR","activeIngredients":"CEPHRADINE","strength":"125MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANSPOR","activeIngredients":"CEPHRADINE","strength":"250MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANSPOR","submission":"CEPHRADINE","actionType":"125MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANSPOR","submission":"CEPHRADINE","actionType":"250MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.