ANDA 201999

TEVA PHARMS USA INC

FDA Drug Application

Application #201999

Application Sponsors

ANDA 201999

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2017-09-11

Submissions Property Types

ORIG

1

Null

17

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201999
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"EQ 0.125MG BASE\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-11
        )

)