ANDA 207420

ASCENT PHARMS INC

FDA Drug Application

Application #207420

Application Sponsors

ANDA 207420

ASCENT PHARMS 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	2019-02-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207420
            [companyName] => ASCENT PHARMS 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":"02\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-25
        )

)