ANDA 090176

BRECKENRIDGE

FDA Drug Application

Application #090176

Application Sponsors

ANDA 090176

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

EQ 0.125MG BASE/SPRAY

0

AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2015-07-28
LABELING; Labeling	SUPPL	4	AP	2021-04-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	4	Null	7
SUPPL	7	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90176
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"EQ 0.125MG BASE\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZELASTINE HYDROCHLORIDE","submission":"AZELASTINE HYDROCHLORIDE","actionType":"EQ 0.125MG BASE\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)