NDA 018050

UCB INC

FDA Drug Application

Application #018050

Application Sponsors

NDA 018050

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/5ML

0

CORSYM

CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-04-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18050
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CORSYM","activeIngredients":"CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX","strength":"EQ 4MG MALEATE\/5ML;EQ 37.5MG HCL\/5ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CORSYM","submission":"CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX","actionType":"EQ 4MG MALEATE\/5ML;EQ 37.5MG HCL\/5ML","submissionClassification":"SUSPENSION, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)