ANDA 202116

ALVOGEN

FDA Drug Application

Application #202116

Application Sponsors

ANDA 202116

ALVOGEN

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

N/A; Not Applicable	ORIG	1	AP	2011-12-30
REMS; REMS	SUPPL	5	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202116
            [companyName] => ALVOGEN
            [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":"12\/30\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)