ANDA 207610

HI TECH

FDA Drug Application

Application #207610

Application Sponsors

ANDA 207610

HI TECH

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

2019-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207610
            [companyName] => AKORN
            [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":"05\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-17
        )

)