ANDA 077022

EPIC PHARMA LLC

FDA Drug Application

Application #077022

Documents

• Letter: 2004-12-02

Application Sponsors

ANDA 077022

EPIC PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	100MG	0	CILOSTAZOL	CILOSTAZOL
002	TABLET;ORAL	50MG	0	CILOSTAZOL	CILOSTAZOL

FDA Submissions

	ORIG	1	AP	2004-11-23
LABELING; Labeling	SUPPL	2	AP	2006-02-14
LABELING; Labeling	SUPPL	3	AP	2008-02-14
LABELING; Labeling	SUPPL	5	AP	2010-05-27
LABELING; Labeling	SUPPL	7	AP	2010-07-06
LABELING; Labeling	SUPPL	8	AP	2017-03-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-11-18	STANDARD

Submissions Property Types

SUPPL	5	Null	8
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77022
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CILOSTAZOL","activeIngredients":"CILOSTAZOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CILOSTAZOL","submission":"CILOSTAZOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)