ANDA 091444

HIKMA

FDA Drug Application

Application #091444

Application Sponsors

ANDA 091444

HIKMA

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	2014-10-24
LABELING; Labeling	SUPPL	3	AP	2019-05-17	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91444
            [companyName] => HIKMA
            [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
        )

)