ANDA 207584

PADDOCK LABS

FDA Drug Application

Application #207584

Documents

• Letter: 2018-01-08

Application Sponsors

ANDA 207584

PADDOCK LABS

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PADDOCK LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207584
            [companyName] => PADDOCK LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMFENAC SODIUM","activeIngredients":"BROMFENAC SODIUM","strength":"EQ 0.07% ACID","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207584Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-29
        )

)