ANDA 203955

AKORN INC

FDA Drug Application

Application #203955

Documents

• Letter: 2016-04-13

Application Sponsors

ANDA 203955

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INJECTION

150MG/30ML (5MG/ML)

0

ROPIVACAINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-11

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203955
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"150MG\/30ML (5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203955Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-11
        )

)