ANDA 074673

EPIC PHARMA LLC

FDA Drug Application

Application #074673

Application Sponsors

ANDA 074673

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 2MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-02-28
LABELING; Labeling	SUPPL	2	AP	2002-11-12
LABELING; Labeling	SUPPL	8	AP	2015-05-06
LABELING; Labeling	SUPPL	11	AP	2015-05-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	7
SUPPL	11	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74673
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GUANFACINE HYDROCHLORIDE","submission":"GUANFACINE HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GUANFACINE HYDROCHLORIDE","submission":"GUANFACINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)