ANDA 209015

APOTEX INC

FDA Drug Application

Application #209015

Documents

• Letter: 2019-04-18

Application Sponsors

ANDA 209015

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.7% BASE

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209015
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.7% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209015Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-09
        )

)