ANDA 215126

SUN PHARM INDS LTD

FDA Drug Application

Application #215126

Application Sponsors

ANDA 215126

SUN PHARM INDS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

5%

0

LIFITEGRAST

LIFITEGRAST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2023-01-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215126
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIFITEGRAST","activeIngredients":"LIFITEGRAST","strength":"5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-11
        )

)