ANDA 204548

TEVA PHARMS USA

FDA Drug Application

Application #204548

Application Sponsors

ANDA 204548

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;INHALATION

1MG/2ML

0

BUDESONIDE

BUDESONIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-08
LABELING; Labeling	SUPPL	3	AP	2021-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AN

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204548
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"1MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/29\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-04-29
        )

)