ANDA 209954

LUPIN ATLANTIS

FDA Drug Application

Application #209954

Application Sponsors

ANDA 209954

LUPIN ATLANTIS

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, METERED;INHALATION

EQ 0.09MG BASE/INH

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2021-01-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB2

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209954
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.09MG BASE\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-24
        )

)