ANDA 203208

HIKMA

FDA Drug Application

Application #203208

Application Sponsors

ANDA 203208

HIKMA

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-12
LABELING; Labeling	SUPPL	3	AP	2020-10-19	STANDARD
REMS; REMS	SUPPL	4	AP	2018-09-18
LABELING; Labeling	SUPPL	5	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-10-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	7

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203208
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/04\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)