ANDA 204674

ALVOGEN INC

FDA Drug Application

Application #204674

Application Sponsors

ANDA 204674

ALVOGEN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION, ORAL

10%

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AN

CDER Filings

ALVOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204674
            [companyName] => ALVOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"10%","dosageForm":"SOLUTION;INHALATION, ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-11
        )

)