ANDA 213479

NOVITIUM PHARMA

FDA Drug Application

Application #213479

Application Sponsors

ANDA 213479

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	2MG	0	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE
002	TABLET;ORAL	3MG	0	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE
003	TABLET;ORAL	1MG	0	LEVORPHANOL TARTRATE	LEVORPHANOL TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213479
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVORPHANOL TARTRATE","activeIngredients":"LEVORPHANOL TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)