ANDA 207367

APPCO

FDA Drug Application

Application #207367

Application Sponsors

ANDA 207367

APPCO

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

3MG

0

BUDESONIDE

BUDESONIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-04-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-11-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207367
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-07
        )

)