NDA 017714

JUBILANT DRAXIMAGE

FDA Drug Application

Application #017714

Documents

• Letter: 2002-03-20

Application Sponsors

NDA 017714

JUBILANT DRAXIMAGE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

AN-DTPA

TECHNETIUM TC-99M PENTETATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1986-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-05-27	STANDARD
LABELING; Labeling	SUPPL	21	AP	2002-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-12-12	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17714
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)