NDA 018621

SANOFI AVENTIS US

FDA Drug Application

Application #018621

Application Sponsors

NDA 018621

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

NITRO-BID

NITROGLYCERIN

FDA Submissions

	ORIG	1	AP	1982-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-09-21
LABELING; Labeling	SUPPL	10	AP	1989-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-09-21
LABELING; Labeling	SUPPL	13	AP	1992-11-18
LABELING; Labeling	SUPPL	14	AP	1993-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-06-22
LABELING; Labeling	SUPPL	18	AP	1996-07-11
LABELING; Labeling	SUPPL	19	AP	1996-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-12-15
LABELING; Labeling	SUPPL	21	AP	1997-09-29

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18621
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)