ANDA 213068

LUPIN

FDA Drug Application

Application #213068

Application Sponsors

ANDA 213068

LUPIN

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INHALATION

EQ 0.015MG BASE/2ML

0

ARFORMOTEROL TARTRATE

ARFORMOTEROL TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-04-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AN

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213068
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARFORMOTEROL TARTRATE","activeIngredients":"ARFORMOTEROL TARTRATE","strength":"EQ 0.015MG BASE\/2ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-07
        )

)