NDA 013413

UCB INC

FDA Drug Application

Application #013413

Application Sponsors

NDA 013413

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

EQ 0.1MG PHOSPHATE/INH

0

DEXACORT

DEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1962-09-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	1979-08-06	STANDARD
LABELING; Labeling	SUPPL	15	AP	1979-08-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	1989-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1991-09-11	STANDARD
LABELING; Labeling	SUPPL	26	AP	1994-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-07-10	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	30	Null	0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13413
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXACORT","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 0.1MG PHOSPHATE\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXACORT","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 0.1MG PHOSPHATE\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)