ANDA 202998

APOTEX INC

FDA Drug Application

Application #202998

Application Sponsors

ANDA 202998

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

20MG/ML

0

PREGABALIN

PREGABALIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-10-28

Submissions Property Types

ORIG

1

Null

17

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202998
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-28
        )

)