ANDA 213239

HIKMA

FDA Drug Application

Application #213239

Application Sponsors

ANDA 213239

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	500MG	0	DEFERIPRONE	DEFERIPRONE
002	TABLET;ORAL	1GM	0	DEFERIPRONE	DEFERIPRONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-03-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-10-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-14	STANDARD

Submissions Property Types

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

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213239
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERIPRONE","activeIngredients":"DEFERIPRONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-29
        )

)