NDA 018035

JUBILANT DRAXIMAGE

FDA Drug Application

Application #018035

Documents

• Letter: 2002-07-03
• Letter: 2004-03-02
• Letter: 2009-07-13
• Label: 2011-09-29
• Letter: 2010-10-26
• Letter: 2011-09-28
• Review: 2002-08-14
• Label: 2009-07-09
• Label: 2010-10-25

Application Sponsors

NDA 018035

JUBILANT DRAXIMAGE

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	N/A	0	DRAXIMAGE MDP-10	TECHNETIUM TC-99M MEDRONATE
002	INJECTABLE;INJECTION	N/A	1	DRAXIMAGE MDP-25	TECHNETIUM TC-99M MEDRONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1978-11-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-04-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	1979-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-12-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	1988-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-12-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	1996-08-23	STANDARD
LABELING; Labeling	SUPPL	15	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	1999-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2004-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2009-07-08	STANDARD
LABELING; Labeling	SUPPL	29	AP	2010-10-22	UNKNOWN
LABELING; Labeling	SUPPL	32	AP	2011-09-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	24	Null	0
SUPPL	29	Null	6
SUPPL	32	Null	7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18035
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)