PERRIGO UK FINCO FDA Approval ANDA 208111

ANDA 208111

PERRIGO UK FINCO

FDA Drug Application

Application #208111

Application Sponsors

ANDA 208111PERRIGO UK FINCO

Marketing Status

Prescription001

Application Products

001SPRAY, METERED;NASALEQ 0.125MG BASE/SPRAY;0.05MG/SPRAY0AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

PERRIGO UK FINCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208111
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE","activeIngredients":"AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE","strength":"EQ 0.125MG BASE\/SPRAY;0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-18
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.