APOTEX FDA Approval ANDA 208150

ANDA 208150

APOTEX

FDA Drug Application

Application #208150

Application Sponsors

ANDA 208150APOTEX

Marketing Status

Over-the-counter001

Application Products

001SPRAY, METERED;NASAL0.05MG/SPRAY0FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2016-02-29STANDARD
LABELING; LabelingSUPPL5AP2017-10-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL5Null15

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208150
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTICASONE PROPIONATE","activeIngredients":"FLUTICASONE PROPIONATE","strength":"0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/20\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-10-20
        )

)

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