ANDA 213410

ALKEM LABS LTD

FDA Drug Application

Application #213410

Application Sponsors

ANDA 213410

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

0

RUFINAMIDE

RUFINAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213410
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-23
        )

)