ANDA 216361

SLAYBACK PHARMA LLC

FDA Drug Application

Application #216361

Application Sponsors

ANDA 216361

SLAYBACK PHARMA LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

0.025%

0

BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2023-01-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216361
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIMONIDINE TARTRATE","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.025%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/03\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-03
        )

)