ANDA 202526

WATSON LABS INC

FDA Drug Application

Application #202526

Documents

• Letter: 2014-08-28

Application Sponsors

ANDA 202526

WATSON LABS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

0.2%

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-08-27

Submissions Property Types

ORIG

1

Null

19

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202526
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"0.2%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/27\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202526Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-27
        )

)