ANDA 206455

BIONPHARMA INC

FDA Drug Application

Application #206455

Application Sponsors

ANDA 206455

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

0

OMEGA-3-ACID ETHYL ESTERS

OMEGA-3-ACID ETHYL ESTERS

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206455
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEGA-3-ACID ETHYL ESTERS","activeIngredients":"OMEGA-3-ACID ETHYL ESTERS","strength":"1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-07
        )

)