ANDA 090910

ALVOGEN

FDA Drug Application

Application #090910

Documents

• Letter: 2011-11-28

Application Sponsors

ANDA 090910

ALVOGEN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

SODIUM PHENYLBUTYRATE

SODIUM PHENYLBUTYRATE

FDA Submissions

ORIG

1

AP

2011-11-18

Submissions Property Types

ORIG

1

Null

1

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90910
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLBUTYRATE","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM PHENYLBUTYRATE","submission":"SODIUM PHENYLBUTYRATE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)