ANDA 216576

AMNEAL PHARMS LLC

FDA Drug Application

Application #216576

Application Sponsors

ANDA 216576

AMNEAL PHARMS LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SPRAY;NASAL

205.5MCG

0

AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-07-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216576
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"205.5MCG","dosageForm":"SPRAY;NASAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-25
        )

)