ANDA 214603

ASCENT PHARMS INC

FDA Drug Application

Application #214603

Application Sponsors

ANDA 214603

ASCENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

0

GEMFIBROZIL

GEMFIBROZIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ASCENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214603
            [companyName] => ASCENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-13
        )

)