ANDA 215081

MICRO LABS USA

FDA Drug Application

Application #215081

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 215081

MICRO LABS USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

5%

0

LIFITEGRAST

LIFITEGRAST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MICRO LABS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215081
            [companyName] => MICRO LABS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIFITEGRAST","activeIngredients":"LIFITEGRAST","strength":"5%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-10
        )

)