NDA 018141

GE HEALTHCARE

FDA Drug Application

Application #018141

Documents

• Letter: 2007-09-07
• Label: 2007-09-06

Application Sponsors

NDA 018141

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	N/A	0	TECHNETIUM TC 99M MPI MDP	TECHNETIUM TC-99M MEDRONATE KIT
002	INJECTABLE;INJECTION	N/A	0	TECHNETIUM TC 99M MPI MDP	TECHNETIUM TC-99M MEDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-06-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	1980-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-03-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	1981-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1980-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-05-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	1985-05-09
LABELING; Labeling	SUPPL	9	AP	1985-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1989-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-02-17	STANDARD
LABELING; Labeling	SUPPL	20	AP	1988-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-11-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2002-11-25	STANDARD
LABELING; Labeling	SUPPL	29	AP	2007-09-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18141
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M MPI MDP","activeIngredients":"TECHNETIUM TC-99M MEDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TECHNETIUM TC 99M MPI MDP","activeIngredients":"TECHNETIUM TC-99M MEDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/05\/2007","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018141s029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M MPI MDP","submission":"TECHNETIUM TC-99M MEDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TECHNETIUM TC 99M MPI MDP","submission":"TECHNETIUM TC-99M MEDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-09-05
        )

)