ANDA 208436

TEVA PHARMS USA

FDA Drug Application

Application #208436

Application Sponsors

ANDA 208436

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-10-06

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208436
            [companyName] => TEVA PHARMS USA
            [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":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-06
        )

)