ANDA 203376

AKORN

FDA Drug Application

Application #203376

Documents

• Letter: 2014-02-12

Application Sponsors

ANDA 203376

AKORN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.45%

0

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-02-10

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203376
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.45%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203376Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/18\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-18
        )

)