ANDA 210897

LUPIN ATLANTIS

FDA Drug Application

Application #210897

Application Sponsors

ANDA 210897

LUPIN ATLANTIS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;INHALATION

0.5MG/2ML

0

BUDESONIDE

BUDESONIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AN

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210897
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.5MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-09
        )

)