ANDA 212206

TEVA PHARMS USA

FDA Drug Application

Application #212206

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 212206

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

125MG

0

ABIRATERONE ACETATE

ABIRATERONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212206
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABIRATERONE ACETATE","activeIngredients":"ABIRATERONE ACETATE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABIRATERONE ACETATE","submission":"ABIRATERONE ACETATE","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)