ANDA 206529

LUPIN LTD

FDA Drug Application

Application #206529

Application Sponsors

ANDA 206529

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

1.1GM

0

BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206529
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BALSALAZIDE DISODIUM","activeIngredients":"BALSALAZIDE DISODIUM","strength":"1.1GM","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-28
        )

)