ANDA 077954

APOTEX INC

FDA Drug Application

Application #077954

Documents

• Letter: 2008-05-05
• Letter: 2009-05-06

Application Sponsors

ANDA 077954

APOTEX INC

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	2009-04-30
LABELING; Labeling	SUPPL	4	AP	2013-03-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-12-27	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-01-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77954
            [companyName] => APOTEX INC
            [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
        )

)