ANDA 210901

AMNEAL PHARMS LLC

FDA Drug Application

Application #210901

Application Sponsors

ANDA 210901

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.665MG/SPRAY

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210901
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"0.665MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-28
        )

)