Application Sponsors
ANDA 208111 | PERRIGO UK FINCO | |
Marketing Status
Application Products
001 | SPRAY, METERED;NASAL | EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY | 0 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-02-18 | STANDARD |
Submissions Property Types
TE Codes
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
)
)