ANDA 206909

MYLAN PHARMS INC

FDA Drug Application

Application #206909

Application Sponsors

ANDA 206909

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

1.1G

0

BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206909
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BALSALAZIDE DISODIUM","activeIngredients":"BALSALAZIDE DISODIUM","strength":"1.1G","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-01
        )

)