ANDA 203853

ALVOGEN INC

FDA Drug Application

Application #203853

Application Sponsors

ANDA 203853

ALVOGEN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION, ORAL

20%

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2012-06-21

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AN

CDER Filings

ALVOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203853
            [companyName] => ALVOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"20%","dosageForm":"SOLUTION;INHALATION, ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-06-21
        )

)