L PERRIGO CO FDA Approval ANDA 212971

ANDA 212971

L PERRIGO CO

FDA Drug Application

Application #212971

Application Sponsors

ANDA 212971L PERRIGO CO

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET;ORAL60MG0FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE
002TABLET;ORAL180MG0FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-02-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2022-07-08UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2022-11-04

Submissions Property Types

ORIG1Null15
SUPPL9Null7
SUPPL14Null7

CDER Filings

L PERRIGO CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212971
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-24
        )

)

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