ANDA 206112

L PERRIGO CO

FDA Drug Application

Application #206112

Application Sponsors

ANDA 206112

L PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-04-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206112
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-26
        )

)