NDA 019401

UCB INC

FDA Drug Application

Application #019401

Application Sponsors

NDA 019401

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 60MG HYDROCHLORIDE/5ML

0

PSEUDO-12

PSEUDOEPHEDRINE POLISTIREX

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form

ORIG

1

AP

1987-06-19

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19401
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PSEUDO-12","activeIngredients":"PSEUDOEPHEDRINE POLISTIREX","strength":"EQ 60MG HYDROCHLORIDE\/5ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PSEUDO-12","submission":"PSEUDOEPHEDRINE POLISTIREX","actionType":"EQ 60MG HYDROCHLORIDE\/5ML","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)