ANDA 202853

PERRIGO ISRAEL

FDA Drug Application

Application #202853

Application Sponsors

ANDA 202853

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.665MG/SPRAY

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-01-31
LABELING; Labeling	SUPPL	11	AP	2021-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202853
            [companyName] => PERRIGO ISRAEL
            [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\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-31
        )

)