ANDA 203404

APOTEX INC

FDA Drug Application

Application #203404

Application Sponsors

ANDA 203404

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

0.01%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-01-07

Submissions Property Types

ORIG

1

Null

17

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203404
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.01%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/07\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-01-07
        )

)