ANDA 207712

APOTEX

FDA Drug Application

Application #207712

Application Sponsors

ANDA 207712

APOTEX

Marketing Status

• Prescription: 001

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	2017-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2020-11-25	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2022-11-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207712
            [companyName] => APOTEX
            [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":"04\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-28
        )

)