ANDA 202662

EPIC PHARMA LLC

FDA Drug Application

Application #202662

Documents

• Letter: 2015-09-24
• Label: 2015-11-25

Application Sponsors

ANDA 202662

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	5MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
003	TABLET;ORAL	15MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
004	TABLET;ORAL	30MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
005	TABLET;ORAL	20MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-09-22
LABELING; Labeling	SUPPL	4	AP	2017-04-27	STANDARD
REMS; REMS	SUPPL	5	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	19
SUPPL	4	Null	7
SUPPL	5	Null	4

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202662
            [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":"10MG","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"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/22\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202662Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202662Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202662Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)