ANDA 040884

EPIC PHARMA LLC

FDA Drug Application

Application #040884

Application Sponsors

ANDA 040884

EPIC PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

50MG

0

PHENYTOIN

PHENYTOIN

FDA Submissions

ORIG

1

AP

2014-11-28

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40884
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"50MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYTOIN","submission":"PHENYTOIN","actionType":"50MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)