ANDA 202743

PERRIGO ISRAEL

FDA Drug Application

Application #202743

Application Sponsors

ANDA 202743

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

EQ 0.1876MG BASE/SPRAY

0

AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-05-08
LABELING; Labeling	SUPPL	3	AP	2020-11-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-11-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202743
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"EQ 0.1876MG BASE\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/08\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/13\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/13\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-13
        )

)