ANDA 202916

AKORN

FDA Drug Application

Application #202916

Documents

• Letter: 2013-11-20

Application Sponsors

ANDA 202916

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.5% BASE

0

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-09

Submissions Property Types

ORIG

1

Null

42

TE Codes

001

Prescription

AT1

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202916
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202916Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-09
        )

)