ANDA 209567

TEVA PHARMS USA INC

FDA Drug Application

Application #209567

Application Sponsors

ANDA 209567

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE

0

SORAFENIB TOSYLATE

SORAFENIB TOSYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209567
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORAFENIB TOSYLATE","activeIngredients":"SORAFENIB TOSYLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-12
        )

)