NDA 018511

JUBILANT DRAXIMAGE

FDA Drug Application

Application #018511

Documents

• Letter: 2011-09-28
• Label: 2011-09-29
• Label: 2017-12-28
• Letter: 2017-12-29
• Label: 2018-01-10
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2022-10-12
• Label: 2022-10-17

Application Sponsors

NDA 018511

JUBILANT DRAXIMAGE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

1

DRAXIMAGE DTPA

TECHNETIUM TC-99M PENTETATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-08-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-08-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	1999-04-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	1999-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-12-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	2011-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2017-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2014-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2014-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2015-01-05	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2017-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2022-10-12	N/A

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	19	Null	7
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18511
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)