ANDA 207363

HIKMA

FDA Drug Application

Application #207363

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 207363

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

0

RUFINAMIDE

RUFINAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207363
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207363Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-07
        )

)