ANDA 213132

GLENMARK PHARMS LTD

FDA Drug Application

Application #213132

Application Sponsors

ANDA 213132

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.015MG BASE/2ML

0

ARFORMOTEROL TARTRATE

ARFORMOTEROL TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AN

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213132
            [companyName] => GLENMARK PHARMS LTD
            [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":"06\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-22
        )

)