ANDA 201193

HIKMA

FDA Drug Application

Application #201193

Application Sponsors

ANDA 201193

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

300MG/5ML

0

OXCARBAZEPINE

OXCARBAZEPINE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-10-03
LABELING; Labeling	SUPPL	3	AP	2015-07-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-10-28	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201193
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/24\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/24\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-07-24
        )

)