NDA 017944

GE HEALTHCARE

FDA Drug Application

Application #017944

Documents

• Letter: 2003-11-25

Application Sponsors

NDA 017944

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

MPI DMSA KIDNEY REAGENT

TECHNETIUM TC-99M SUCCIMER KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-05-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	1983-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-01-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-11-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-11-25	STANDARD
LABELING; Labeling	SUPPL	18	AP	2003-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2013-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2014-02-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17944
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MPI DMSA KIDNEY REAGENT","activeIngredients":"TECHNETIUM TC-99M SUCCIMER KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MPI DMSA KIDNEY REAGENT","submission":"TECHNETIUM TC-99M SUCCIMER KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)