ANDA 077150

EPIC PHARMA LLC

FDA Drug Application

Application #077150

Application Sponsors

ANDA 077150

EPIC PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

CILOSTAZOL

CILOSTAZOL

FDA Submissions

	ORIG	1	AP	2005-03-11
LABELING; Labeling	SUPPL	2	AP	2008-02-14
LABELING; Labeling	SUPPL	4	AP	2009-09-15
LABELING; Labeling	SUPPL	5	AP	2010-02-26
LABELING; Labeling	SUPPL	6	AP	2017-03-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-11-18	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77150
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CILOSTAZOL","activeIngredients":"CILOSTAZOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CILOSTAZOL","submission":"CILOSTAZOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)