ANDA 076257

EPIC PHARMA LLC

FDA Drug Application

Application #076257

Application Sponsors

ANDA 076257

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	1.25MG	0	GLYBURIDE	GLYBURIDE
002	TABLET;ORAL	2.5MG	0	GLYBURIDE	GLYBURIDE
003	TABLET;ORAL	5MG	0	GLYBURIDE	GLYBURIDE

FDA Submissions

	ORIG	1	AP	2002-06-27
LABELING; Labeling	SUPPL	4	AP	2009-09-18
LABELING; Labeling	SUPPL	5	AP	2010-08-19
LABELING; Labeling	SUPPL	6	AP	2010-06-23
LABELING; Labeling	SUPPL	8	AP	2010-09-30
LABELING; Labeling	SUPPL	10	AP	2015-04-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-04-13	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	5	Null	8
SUPPL	6	Null	8
SUPPL	10	Null	7
SUPPL	15	Null	7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76257
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYBURIDE","submission":"GLYBURIDE","actionType":"1.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE","submission":"GLYBURIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE","submission":"GLYBURIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)