ANDA 202795

AKORN INC

FDA Drug Application

Application #202795

Documents

• Letter: 2013-01-25

Application Sponsors

ANDA 202795

AKORN INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.025%;0.3%

0

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-01-24

Submissions Property Types

ORIG

1

Null

19

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202795
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","strength":"0.025%;0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202795Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-01-24
        )

)