ANDA 204660

AMNEAL PHARMS LLC

FDA Drug Application

Application #204660

Application Sponsors

ANDA 204660

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

EQ 0.125MG BASE/SPRAY

0

AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-28

Submissions Property Types

ORIG

1

Null

42

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204660
            [companyName] => AMNEAL
            [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":"08\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/25\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-03-25
        )

)