NDA 019798

SANOFI AVENTIS US

FDA Drug Application

Application #019798

Application Sponsors

NDA 019798

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;NASAL

0.055MG/INH

0

NASACORT

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-07-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	1994-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-11-21	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	1996-05-20	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-07-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-08-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19798
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"NASACORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.055MG\/INH","dosageForm":"AEROSOL, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NASACORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.055MG\/INH","submissionClassification":"AEROSOL, METERED;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)