NDA 019530

B BRAUN

FDA Drug Application

Application #019530

Application Sponsors

NDA 019530

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100MG/ML;100MG/ML

0

UCEPHAN

SODIUM BENZOATE; SODIUM PHENYLACETATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination

ORIG

1

AP

1987-12-23

PRIORITY

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19530
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"UCEPHAN","activeIngredients":"SODIUM BENZOATE; SODIUM PHENYLACETATE","strength":"100MG\/ML;100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"UCEPHAN","submission":"SODIUM BENZOATE; SODIUM PHENYLACETATE","actionType":"100MG\/ML;100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)