ANDA 208371

RISING

FDA Drug Application

Application #208371

Application Sponsors

ANDA 208371

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

ABIRATERONE ACETATE

ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208371
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-25
        )

)