ANDA 090918

APOTEX INC

FDA Drug Application

Application #090918

Documents

• Letter: 2018-01-08

Application Sponsors

ANDA 090918

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.2% BASE

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2017-12-05
LABELING; Labeling	SUPPL	5	AP	2020-08-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AT

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90918
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OLOPATADINE HYDROCHLORIDE","submission":"OLOPATADINE HYDROCHLORIDE","actionType":"EQ 0.2% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)