ANDA 208150

APOTEX

FDA Drug Application

Application #208150

Application Sponsors

ANDA 208150

APOTEX

Marketing Status

• Over-the-counter: 001

Application Products

001

SPRAY, METERED;NASAL

0.05MG/SPRAY

0

FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

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
        )

)