ANDA 208306

AKORN

FDA Drug Application

Application #208306

Documents

• Letter: 2017-11-08

Application Sponsors

ANDA 208306

AKORN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208306
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208306Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-27
        )

)