ANDA 090895

EPIC PHARMA LLC

FDA Drug Application

Application #090895

Documents

• Letter: 2009-09-01

Application Sponsors

ANDA 090895

EPIC PHARMA LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	15MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
003	TABLET;ORAL	30MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-08-24
LABELING; Labeling	SUPPL	8	AP	2017-06-01	STANDARD
REMS; REMS	SUPPL	10	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	1
SUPPL	8	Null	7
SUPPL	10	Null	4

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90895
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)