ANDA 212462

QILU

FDA Drug Application

Application #212462

Application Sponsors

ANDA 212462

QILU

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	ABIRATERONE ACETATE	ABIRATERONE ACETATE
002	TABLET;ORAL	500MG	0	ABIRATERONE ACETATE	ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-03-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212462
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-27
        )

)