NDA 020233

ASTRAZENECA

FDA Drug Application

Application #020233

Documents

• Review: 2003-08-07

Application Sponsors

NDA 020233

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;NASAL

0.032MG/INH

0

RHINOCORT

BUDESONIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-11-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	1996-02-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	1998-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-10-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2000-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20233
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RHINOCORT","activeIngredients":"BUDESONIDE","strength":"0.032MG\/INH","dosageForm":"AEROSOL, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RHINOCORT","submission":"BUDESONIDE","actionType":"0.032MG\/INH","submissionClassification":"AEROSOL, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)