TEVA PHARMS USA INC FDA Approval ANDA 209567

ANDA 209567

TEVA PHARMS USA INC

FDA Drug Application

Application #209567

Application Sponsors

ANDA 209567TEVA PHARMS USA INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 200MG BASE0SORAFENIB TOSYLATESORAFENIB TOSYLATE

FDA Submissions

UNKNOWN; ORIG1TA2019-04-15STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

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
        )

)

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