ANDA 203918

PAR PHARM

FDA Drug Application

Application #203918

Application Sponsors

ANDA 203918

PAR PHARM

Marketing Status

• Prescription: 001

Application Products

001

POWDER;ORAL

3GM/TEASPOONFUL

0

SODIUM PHENYLBUTYRATE

SODIUM PHENYLBUTYRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-15

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203918
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLBUTYRATE","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"3GM\/TEASPOONFUL","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-15
        )

)