ANDA 211120

LAURUS LABS LTD

FDA Drug Application

Application #211120

Application Sponsors

ANDA 211120

LAURUS LABS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-04-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211120
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MACITENTAN","activeIngredients":"MACITENTAN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-14
        )

)