ANDA 204037

HIKMA

FDA Drug Application

Application #204037

Application Sponsors

ANDA 204037

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-09-04	UNKNOWN
REMS; REMS	SUPPL	7	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	7	Null	15

TE Codes

001

Prescription

AA

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204037
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-7","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/04\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)