ANDA 208024

HI TECH

FDA Drug Application

Application #208024

Application Sponsors

ANDA 208024

HI TECH

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

2019-04-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AKORN OPERATING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208024
            [companyName] => AKORN OPERATING
            [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":"04\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-17
        )

)