NDA 014242

UCB INC

FDA Drug Application

Application #014242

Application Sponsors

NDA 014242

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL;NASAL

EQ 0.1MG PHOSPHATE/INH

0

DEXACORT

DEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1965-12-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	1977-09-12
LABELING; Labeling	SUPPL	13	AP	1978-10-19
LABELING; Labeling	SUPPL	14	AP	2007-12-07
LABELING; Labeling	SUPPL	16	AP	1979-08-06
LABELING; Labeling	SUPPL	18	AP	1979-08-17
LABELING; Labeling	SUPPL	19	AP	2007-12-07
LABELING; Labeling	SUPPL	20	AP	1981-11-18
LABELING; Labeling	SUPPL	21	AP	2007-12-07
LABELING; Labeling	SUPPL	22	AP	2007-12-07
LABELING; Labeling	SUPPL	23	AP	2007-12-07
LABELING; Labeling	SUPPL	24	AP	2007-12-07
LABELING; Labeling	SUPPL	25	AP	1989-05-18
LABELING; Labeling	SUPPL	26	AP	2007-12-07
LABELING; Labeling	SUPPL	27	AP	2007-12-07
LABELING; Labeling	SUPPL	28	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1991-09-11	STANDARD
LABELING; Labeling	SUPPL	30	AP	1994-05-03	STANDARD
LABELING; Labeling	SUPPL	31	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	32	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	33	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1995-07-10	STANDARD

Submissions Property Types

SUPPL	29	Null	0
SUPPL	34	Null	0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14242
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXACORT","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 0.1MG PHOSPHATE\/INH","dosageForm":"AEROSOL;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXACORT","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 0.1MG PHOSPHATE\/INH","submissionClassification":"AEROSOL;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)