ANDA 204988

HIKMA

FDA Drug Application

Application #204988

Documents

• Letter: 2016-05-18
• Label: 2016-06-01

Application Sponsors

ANDA 204988

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	200MG	0	RUFINAMIDE	RUFINAMIDE
002	TABLET;ORAL	400MG	0	RUFINAMIDE	RUFINAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-05-16

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204988
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/16\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204988Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/16\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204988Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204988Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/16\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-16
        )

)