ANDA 206724

ALVOGEN

FDA Drug Application

Application #206724

Application Sponsors

ANDA 206724

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

3MG

0

BUDESONIDE

BUDESONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206724
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-23
        )

)