ANDA 212429

AUROLIFE PHARMA LLC

FDA Drug Application

Application #212429

Application Sponsors

ANDA 212429

AUROLIFE PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	5MG/5ML	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	SOLUTION;ORAL	100MG/5ML	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212429
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-27
        )

)