ANDA 204929

RISING

FDA Drug Application

Application #204929

Application Sponsors

ANDA 204929

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

600MG

0

ZILEUTON

ZILEUTON

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-17
LABELING; Labeling	SUPPL	2	AP	2019-08-05	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204929
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZILEUTON","activeIngredients":"ZILEUTON","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/05\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-05
        )

)