NDA 018770

SANOFI AVENTIS US

FDA Drug Application

Application #018770

Application Sponsors

NDA 018770

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.37MG/INH

0

TORNALATE

BITOLTEROL MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1984-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-01-17	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2007-12-07
LABELING; Labeling	SUPPL	5	AP	1986-01-09
LABELING; Labeling	SUPPL	7	AP	1986-08-06
LABELING; Labeling	SUPPL	8	AP	2007-12-07
LABELING; Labeling	SUPPL	10	AP	1986-09-24
EFFICACY; Efficacy	SUPPL	11	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-04-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	1991-07-09
LABELING; Labeling	SUPPL	14	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	15	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	16	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-01-20	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	12	Null	0
SUPPL	17	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18770
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORNALATE","activeIngredients":"BITOLTEROL MESYLATE","strength":"0.37MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORNALATE","submission":"BITOLTEROL MESYLATE","actionType":"0.37MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)