ANDA 207012

MYLAN PHARMS INC

FDA Drug Application

Application #207012

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 207012

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

200MG

0

SORAFENIB

SORAFENIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-05-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207012
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORAFENIB TOSYLATE","activeIngredients":"SORAFENIB TOSYLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-10
        )

)