ANDA 208795

HI TECH

FDA Drug Application

Application #208795

Application Sponsors

ANDA 208795

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-04-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AA

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208795
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)