ANDA 214009

PHARMACEUTICALS LTD CANADA

FDA Drug Application

Application #214009

Application Sponsors

ANDA 214009

PHARMACEUTICALS LTD CANADA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

0

RUFINAMIDE

RUFINAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-10-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PHARMACEUTICALS LTD CANADA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214009
            [companyName] => PHARMACEUTICALS LTD CANADA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-19
        )

)