ANDA 210686

MSN

FDA Drug Application

Application #210686

Application Sponsors

ANDA 210686

MSN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

ABIRATERONE ACETATE

ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-07-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-09-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MSN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210686
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-10
        )

)