ANDA 208817

HI TECH

FDA Drug Application

Application #208817

Application Sponsors

ANDA 208817

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208817
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)