ANDA 207957

HIKMA

FDA Drug Application

Application #207957

Application Sponsors

ANDA 207957

HIKMA

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	2016-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2016-12-29	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2019-11-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	7

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207957
            [companyName] => HIKMA
            [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":"05\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/29\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/02\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-27
        )

)