ANDA 207306

CIPLA LTD

FDA Drug Application

Application #207306

Documents

• Letter: 2021-07-07

Application Sponsors

ANDA 207306

CIPLA LTD

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

2017-08-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AN

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207306
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARFORMOTEROL TARTRATE","activeIngredients":"ARFORMOTEROL TARTRATE","strength":"","dosageForm":"SOLUTION;INHALATION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/31\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-31
        )

)