ANDA 208453

APOTEX

FDA Drug Application

Application #208453

Documents

• Letter: 2018-11-05

Application Sponsors

ANDA 208453

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

ABIRATERONE ACETATE

ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-31	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-11-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-11-22	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208453
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208453Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-31
        )

)