ANDA 208416

DR REDDYS LABS LTD

FDA Drug Application

Application #208416

Application Sponsors

ANDA 208416

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

ABIRATERONE ACETATE

ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-12-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-12-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	31

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208416
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-18
        )

)