ANDA 209158

PERRIGO UK FINCO

FDA Drug Application

Application #209158

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 209158

PERRIGO UK FINCO

Marketing Status

• None (Tentative Approval): 001

Application Products

001

GEL;TOPICAL

0.33%

0

BRIMONIDINE

BRIMONIDINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-07-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209158
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIMONIDINE","activeIngredients":"BRIMONIDINE","strength":"0.33%","dosageForm":"GEL;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-31
        )

)